Endoscopic tissue anchor deployment

ABSTRACT

An endoscopic tissue anchor deployment device includes a handle, an elongated shaft defining an internal lumen, and an end effector attached to the distal end of the elongated shaft. A tissue anchor catheter is removably inserted through the lumen of the elongated shaft, the catheter having a tissue anchor assembly that is deployable from its distal end. The handle may include a pin and track assembly that define a series of handle actuation steps corresponding to deployment steps for the deployment device end effector and the tissue anchor catheter. In some embodiments, the handle includes a catheter stop member that prevents movement of the tissue anchor catheter under certain circumstances, and a handle stop member that prevents actuation of the handle under certain circumstances.

RELATED APPLICATION DATA

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/432,537 filed on Jan. 13, 2011. Application Nos. 61/432,537;61/073,296; 61/172,169 and Ser. No. 12/486,578, are incorporated hereinby reference.

BACKGROUND

This application relates to methods and apparatus for manipulatingand/or securing tissue. More particularly, the present disclosurerelates to methods and apparatus for manipulating and/or securing tissueendoscopically and/or endolumenally, for instance, to form tissue folds,to approximate regions of tissue, and/or to deploy tissue anchors.

A number of surgical techniques have been developed to treat variousgastrointestinal disorders. One example of a pervasive disorder ismorbid obesity. Conventional surgical treatment for morbid obesitytypically includes, e.g., bypassing an absorptive surface of the smallintestine, or reducing the stomach size. However, many conventionalsurgical procedures may present numerous life-threatening post-operativecomplications, and may cause atypical diarrhea, electrolytic imbalance,unpredictable weight loss and reflux of nutritious chyme proximal to thesite of the anastomosis.

Furthermore, the sutures or staples that are often used in surgicalprocedures for gastrointestinal disorders typically require extensivetraining by the clinician to achieve competent use, and may concentratesignificant force over a small surface area of the tissue, therebypotentially causing the suture or staple to tear through the tissue.Many of the surgical procedures require regions of tissue within thebody to be approximated towards one another and reliably secured. Thegastrointestinal lumen, for instance, includes four tissue layers, wherethe mucosa layer is the inner-most tissue layer followed by connectivetissue, the muscularis layer, and where the serosa layer is theouter-most tissue layer.

One problem with conventional gastrointestinal reduction systems is thatthe anchors (or staples) should engage at least the muscularis tissuelayer in order to provide a proper foundation. In other words, themucosa and connective tissue layers typically are not strong enough tosustain the tensile loads imposed by normal movement of the stomach wallduring ingestion and processing of food. In particular, these layerstend to stretch elastically rather than firmly hold the anchors (orstaples) in position, and accordingly, the more rigid muscularis and/orserosa layer should ideally be engaged. This problem of capturing themuscularis or serosa layers becomes particularly acute where it isdesired to place an anchor or other apparatus transesophageally ratherthan intra-operatively, since care must be taken in piercing the toughstomach wall not to inadvertently puncture adjacent tissue or organs.

One conventional method for securing anchors within a body lumen to thetissue is to utilize sewing devices to suture the stomach wall intofolds. This procedure typically involves advancing a sewing instrumentthrough the working channel of an endoscope and into the stomach andagainst the stomach wall tissue. The contacted tissue is then typicallydrawn into the sewing instrument where one or more sutures or tags areimplanted to hold the suctioned tissue in a folded condition known as aplication. Another method involves manually creating sutures forsecuring the plication.

One of the problems associated with these types of procedures is thetime and number of intubations needed to perform the various proceduresendoscopically. Another problem is the time required to complete aplication from the surrounding tissue with the body lumen. In the periodof time that a patient is anesthetized, procedures such as for thetreatment of morbid obesity, revision of obesity procedures, or for GERDmust be performed to completion. Accordingly, the placement andsecurement of the tissue plication should ideally be relatively quickand performed with a high degree of confidence.

Another problem with conventional methods involves ensuring that thestaple, knotted suture, or clip is secured tightly against the tissueand that the newly created plication will not relax under any slackwhich may be created by slipping staples, knots, or clips. Otherconventional tissue securement devices such as suture anchors, twistties, crimps, etc. are also often used to prevent sutures from slippingthrough tissue. However, many of these types of devices are typicallylarge and unsuitable for low-profile delivery through the body, e.g.,transesophageally.

Moreover, when grasping or clamping onto or upon the layers of tissuewith conventional anchors, sutures, staples, clips, etc., many of thesedevices are configured to be placed only after the tissue has beenplicated and not during the actual plication procedure.

SUMMARY

In one general aspect, devices according to the present inventioninclude mechanisms for deploying tissue anchors and tissue anchorassemblies into and/or through tissue within a patient. In someembodiments, the devices are introduced endolumenally (e.g.,transorally, transanally, etc.) into the patient's body and into oraround the gastrointestinal (“GI”) tract. Once the instruments arepositioned within the stomach or other target site, tissue at the targetsite is temporarily engaged or grasped and the engaged tissue ismanipulated by a surgeon or practitioner from outside the patient'sbody.

In engaging, manipulating, and/or securing the tissue, various methodsand devices may be implemented. For instance, tissue securement devicesmay be delivered and positioned via an endoscopic apparatus forcontacting a tissue wall, creating one or more tissue folds, anddeploying one or more tissue anchors through the tissue fold(s). Thetissue anchor(s) may be disposed through the muscularis and/or serosalayers of the tissue. An endoscopic access device having an elongatebody, a steerable distal portion, and multiple lumens definedtherethrough may be advanced into a patient per-orally and through theesophagus. A tissue manipulation assembly positioned at the distal endof a tubular body may be passed through the endoscopic access device forengaging and securing the tissue.

Utilizing one or more of the instruments, the endoscopic access devicemay be used to pass the flexible body therethrough and into the stomachwhere it may be used to engage tissue and form folds, invaginations, orother reconfigurations of tissue which are secured via expandable tissueanchors expelled from the tissue manipulation assembly. Any number oftissue folds and/or invaginations, i.e., one or more, may be created.

In an embodiment, a delivery catheter is advanced through a patient'smouth and esophagus and into the patient's stomach or other target site,with the delivery catheter including a flexible tube having a needle atits distal end and with a first tissue anchor assembly being containedwithin the flexible tube of the delivery catheter. One or moreinstruments associated with the delivery catheter are used to form afirst tissue fold in the tissue at the target site, the tissue foldpreferably including a serosa-to-serosa contact of tissue on theperitoneal surface of the tissue. The needle of the delivery catheter ispassed through the first tissue fold, and a first tissue anchor assemblyis deployed from the delivery catheter through the first tissue fold tothereby secure the first tissue fold. A plurality of additional tissuefolds may be also secured in the tissue.

In some embodiments, the devices and systems include an endoscopicaccess device, a tissue manipulation assembly, and a needle deploymentassembly containing a tissue anchor or tissue anchor assembly. Thetissue manipulation assembly includes a handle having several optionalfeatures and functions, including a handle stop member for preventingactuation of the handle under certain circumstances, a needle stopmember for preventing advancement of the needle deployment assemblyunder certain circumstances, a pin and track mechanism that defines aseries of handle actuation steps corresponding to deployment steps forthe tissue manipulation assembly and the needle deployment assembly, andothers.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic representation of a tissue anchor assembly.

FIG. 1B is a schematic representation of a tissue anchor assemblysecuring a tissue fold.

FIG. 2A is a perspective view of a cinch.

FIG. 2B is a cross-sectional view of the cinch of FIG. 2A.

FIG. 3 is a side view of a tissue anchor delivery device, including atissue manipulation assembly and a needle deployment assembly.

FIG. 4 is a side view of the tissue manipulation assembly of FIG. 3.

FIGS. 5A and 5B are perspective views of an end effector of the tissuemanipulation assembly of FIGS. 3 and 4.

FIG. 6 is an exploded view of the needle deployment assembly of FIG. 3.

FIG. 7 is a side view of a tissue manipulation assembly extending fromthe distal end of a lumen of an endoscopic access device and deploying atissue anchor assembly through a tissue fold.

FIGS. 8A and 8B are perspective views of endoscopic access devices.

FIG. 9 is a perspective view of an actuator mechanism for a tissueanchor delivery device.

FIG. 10 is a perspective view of the actuator mechanism of FIG. 9 withportions of the handle body and main housing removed for clarification.

FIG. 11 is a cross-sectional view of the actuator mechanism of FIG. 9.

FIGS. 12A-G are side views of an embodiment of a handle lock mechanismof the actuator mechanism of FIG. 9.

FIGS. 13A-B are perspective views of another embodiment of a needledeployment assembly.

FIGS. 14A-C are cross-sectional views of a rigid body portion of theneedle deployment assembly of FIGS. 13A-B.

FIGS. 15A-C are perspective views of the needle deployment assembly ofFIGS. 13A-B with the flexible catheter body removed for clarification.

FIGS. 16A-B are perspective and cross-sectional views, respectively, ofan anchor assembly in an expanded or deployed state.

FIG. 17 is a perspective view of an anchor assembly in an unexpanded ordelivery state.

FIG. 18 is an exploded view of a needle deployment assembly actuationmechanism of the actuator mechanism of FIG. 9.

FIG. 19 is a perspective view of a needle deployment assembly beingloaded into an actuator mechanism.

FIG. 20 is a cross-sectional view of a proximal portion of the tubularbody of an anchor delivery device.

FIG. 21 is a side view of another embodiment of an actuator mechanismfor a tissue anchor delivery device.

FIGS. 22A-B are perspective views of the actuator mechanism of FIG. 21.

FIG. 23 is a side view of the actuator mechanism of FIG. 21 with aportion of the main housing removed for clarification.

FIG. 24 is a side view of the actuator mechanism of FIG. 21 with aportion of the main housing and handle body removed for clarification,shown in the fully closed position.

FIGS. 25A-B are side views of the actuator mechanism of FIG. 21 (with aportion of the main housing and handle body removed for clarification)including a needle deployment assembly being loaded into the proximalend of the device.

FIGS. 26A-B are side views of a portion of the interior of a mainhousing of the actuator mechanism of FIG. 21.

FIGS. 27A-C are side views of the actuator mechanism of FIG. 21 (withportions of the main housing removed for clarification) including aneedle deployment assembly being loaded into the proximal end of thedevice.

FIG. 27D is a perspective view of an embodiment of a needle stop arm.

FIGS. 28A-C are side and top views of the actuator mechanism of FIG. 21(with a portion of the main housing removed for clarification) includinga needle deployment assembly being loaded into the proximal end of thedevice.

FIGS. 29A-C are a perspective view and two bottom views of an embodimentof a needle launch button.

FIGS. 30A-C are two side views and a top view, respectively, of anembodiment of a needle deployment assembly, with the outer sheathremoved for clarification.

FIG. 30D is a cross-sectional view of an embodiment of a one way snapfeature of the needle deployment assembly of FIGS. 30A-C.

FIGS. 31A-C are side, top, and perspective views, respectively, of anembodiment of a suture deployment button of the needle deploymentassembly of FIGS. 30A-C.

FIG. 32A is a side view of the needle deployment assembly of FIGS.30A-C, with the outer sheath removed for clarification.

FIGS. 32B-C are side views of components of the needle deploymentassembly of FIGS. 30A-C.

FIG. 33 is a side view of a suture deployment button, cinch bushing, andlooped cable of the needle deployment assembly of FIGS. 30A-C.

FIGS. 34A-B are partial cross-sectional views of the suture deploymentbutton and looped cable shown in FIG. 33.

FIGS. 35A-C are cross-sectional views of a flexible catheter portion ofthe needle deployment assembly of FIGS. 30A-C.

FIGS. 36A-C are cross-sectional views of a flexible catheter portion ofthe needle deployment assembly of FIGS. 30A-C, showing the progress of adeployment of an anchor assembly.

FIG. 37 is a side view of an embodiment of a distal portion of a launchtube of the tissue anchor delivery device shown in FIG. 3.

FIGS. 38A-C are a bottom view, side view, and expanded bottom view,respectively, of another embodiment of a distal portion of a launch tubeof the tissue anchor delivery device shown in FIG. 3.

FIGS. 39A-C are a top view, side view, and expanded side view,respectively, of another embodiment of a distal portion of a launch tubeof the tissue anchor delivery device shown in FIG. 3.

FIGS. 40A-B are a bottom view and expanded bottom view, respectively, ofanother embodiment of a distal portion of a launch tube of the tissueanchor delivery device shown in FIG. 3.

FIGS. 41A-C are a perspective view and two side views, respectively, ofan embodiment of an end effector of the tissue anchor delivery deviceshown in FIG. 3.

FIGS. 42A-D are a perspective view and three side views, respectively,of another embodiment of an end effector of the tissue anchor deliverydevice shown in FIG. 3.

FIGS. 43A-B are side views of the end effectors shown in FIGS. 41A-C and42A-D, respectively.

FIG. 44A is a side view of another embodiment of a tissue manipulationassembly.

FIGS. 44B-C are side views of an actuator mechanism of the tissuemanipulation assembly of FIG. 44A shown in a closed and an openposition, respectively.

FIGS. 45A-B are side views of an alternative embodiment of a distal endeffector.

FIGS. 46A-B are a perspective and a top view, respectively, of the upperand lower fixed bails of the distal end effector shown in FIGS. 45A-B.

FIGS. 47A-B are side views of the upper fixed bail, launch tube, andpivot of the distal end effector shown in FIGS. 45A-B.

FIGS. 48A-B are side views of the upper fixed bail, launch tube, andpivot of another embodiment of the distal end effector shown in FIGS.45A-B.

FIG. 49 is a side view of an embodiment of a distal end effector.

FIGS. 50A-B and 51 are perspective views an alternative embodiment of adistal end effector.

FIGS. 52A-B are a cross-sectional view and a perspective view,respectively, of a portion of the distal end effector shown in FIG. 49.

FIGS. 53A-B are a perspective view and a side view, respectively, of anembodiment of a pivot having a cutting blade.

FIGS. 54A-B are a perspective view and a side view, respectively, ofanother embodiment of a pivot having a cutting blade.

DETAILED DESCRIPTION

Endoscopic and endolumenal surgical methods and devices are describedherein. In several embodiments, the methods entail performing surgerythrough a patient's mouth or other natural orifices, reducing oreliminating the need for external incisions into the body. Operatingthrough the body's natural orifices offers promise for faster healingtimes, less scarring and less pain which could lead to reducedhospitalization and quicker recovery.

USGI Medical, Inc. of San Clemente, Calif. has developed several devicesand methods that facilitate endoscopic and endolumenal diagnostic andtherapeutic procedures. Several endoscopic access devices are described,for example, in the following United States patent applications:

TABLE 1 U.S. patent application Ser. No. Filing Date 10/346,709 Jan. 15,2003 10/458,060 Jun. 9, 2003 10/797,485 Mar. 9, 2004 11/129,513 May 13,2005 11/365,088 Feb. 28, 2006 11/738,297 Apr. 20, 2007 11/750,986 May18, 2007 12/061,591 Apr. 2, 2008

Several tissue manipulation and tissue anchor delivery devices aredescribed in the following United States patent applications:

TABLE 2 U.S. patent application Ser. No. Filing Date 10/612,109 Jul. 1,2003 10/639,162 Aug. 11, 2003 10/672,375 Sept. 26, 2003 10/734,547 Dec.12, 2003 10/734,562 Dec. 12, 2003 10/735,030 Dec. 12, 2003 10/840,950May 7, 2004 10/955,245 Sept. 29, 2004 11/070,863 Mar. 1, 2005

Endolumenal tissue grasping devices are described in several of theUnited States patent applications listed above, and in the followingUnited States patent applications:

TABLE 3 U.S. patent application Ser. No. Filing Date 11/736,539 Apr. 17,2007 11/736,541 Apr. 17, 2007

Tissue anchors are described in several of the United States patentapplications listed above, and in the following United States patentapplications:

TABLE 4 U.S. patent application Ser. No. Filing Date 10/841,411 May 7,2004 11/404,423 Apr. 14, 2006 11/773,933 Jul. 5, 2007

Each of the foregoing patent applications is hereby incorporated byreference in its entirety.

Several endoscopic and/or endolumenal therapeutic procedures describedin the above patent applications include the steps of grasping tissue toform a tissue fold and deploying or implanting a fold retaining device(e.g., a tissue anchor assembly) that is used to maintain the fold.Other such procedures include the steps of grasping at least twosections of tissue, approximating the at least two sections of tissue,and deploying or implanting a tissue retaining device (e.g., a tissueanchor assembly) that is used to maintain the at least two sections oftissue in their approximated state. For simplicity, the discussionherein will describe tissue anchor assemblies holding tissue folds, withit being understood that other portions or sections of tissue that donot constitute tissue folds are suitably retained by the tissue anchorassemblies. The following sections include descriptions of severalembodiments of devices that are suitable for performing these and otherendoscopic and/or endolumenal surgical procedures.

A tissue anchor assembly is used to maintain a tissue fold in tissuesuch as that present in the gastrointestinal lumen. Suitable tissueanchor assemblies include tissue anchors such as those described inseveral of the United States Patent Applications incorporated byreference above, including Ser. Nos. 10/841,411, 11/404,423, and11/773,933. A schematic representation of a suitable tissue anchorassembly 48 is shown in FIG. 1A.

Preferably, the tissue anchor assemblies include a pair of tissueanchors 50 a, 50 b slidably retained by a connecting member, such as asuture 52. A locking mechanism, such as a cinch 62, is also slidablyretained on the suture 52. The cinch 62 is configured to provide acinching force against the anchors 50 a, 50 b in order to impart atension force on the suture. Accordingly, the tissue anchor assembly 48is adapted to hold a fold F of tissue T, as shown in FIG. 1B.

The cinch 62 functions by providing unidirectional translation over thesuture thereby providing the ability to advance the tissue anchor(s) 50into apposition and to retain the anchor(s) in place. An embodiment of acinch 62 is shown in FIGS. 2A-B. The cinch includes a generally tubularbody 63 defining an internal lumen 64. A plurality of inwardly facinglevers 65 are formed integrally with the side wall of the tubular body63. Three levers 65 are included in the cinch embodiment shown in thefigures. In other embodiments, fewer levers (e.g., one or two) or morethan three levers are used. In some embodiments, each lever 65 isflexibly biased to spring radially inward into the tubular body 63 or todeflect radially outward upon a suture 52 or other connector memberpassing therethrough. During translation of the suture 52 in a firstdirection (i.e., from left to right as viewed in FIG. 2B), the suture 52is allowed to freely pass through the tubular body and past theplurality of levers due to a slight radially outward pivot of each ofthe levers. However, when the suture is urged in the second direction(i.e., from right to left as viewed in FIG. 2B), the levers 65 pivotradially inward, cinching down upon the suture against the inner surfaceof the tubular body 63. The cinching levers 65 are configured to preventor inhibit the overcinching or cutting of the suture 52.

In other embodiments of the cinch 62, the levers 65 are substantiallyrigid, and do not pivot or deflect. In those embodiments, the levers 65create a sufficiently tortuous path for the suture 52 (or otherconnector) to traverse that the cinch effectively binds the suture fromtranslating in the first direction, while allowing translation in thesecond direction.

The cinches 62 described herein are formed of biocompatible and/orbioabsorbable materials such as those described above. In severalembodiments, the cinch is formed of nickel-titanium alloy (Nitinol). Thesize and shape of the cinch are primarily dependent upon the size andshape of the other parts of the tissue anchor assembly, such as thediameter and materials forming the suture 52 (or other connector) and/orthe size of the passage in the tissue anchors 50. Additional embodimentsof cinches and additional cinching mechanisms suitable for use in thetissue anchor assemblies 48 are described and illustrated in U.S. patentapplication Ser. Nos. 10/612,170; 10/840,950; 10/840,951; 10/841,245;10/841,411; 10/865,736; 11/036,866; 11/036,946; and 11/404,423, each ofwhich is hereby incorporated by reference in its entirety (including allreferences cited therein) as if fully set forth herein.

In several embodiments, a delivery device is used to deploy the tissueanchors and tissue anchor assemblies 48 endoscopically or endolumenally.An example of a suitable delivery device is shown in FIG. 3, and isdescribed in more detail in U.S. patent application Ser. No. 11/070,846,which is hereby incorporated by reference in its entirety (including allreferences cited therein) as if fully set forth herein. The deliverydevice 208 is described briefly below.

In manipulating tissue or creating tissue folds, a device having adistal end effector may be advanced endoscopically or endolumenally,e.g., transorally, transgastrically, etc., into the patient's body,e.g., the stomach. The tissue may be engaged or grasped and the engagedtissue may be manipulated by a surgeon or practitioner from outside thepatient's body. Examples of creating and forming tissue plications aredescribed in further detail in U.S. patent application Ser. No.10/955,245, filed Sep. 29, 2004, which is incorporated herein byreference, as well as U.S. patent application Ser. No. 10/735,030, filedDec. 12, 2003, which is also incorporated herein by reference in itsentirety.

In engaging, manipulating, and/or securing the tissue, various methodsand devices may be implemented. For instance, tissue securement devicesmay be delivered and positioned via an endoscopic apparatus forcontacting a tissue wall of the gastrointestinal lumen, creating one ormore tissue folds, and deploying one or more tissue anchors through thetissue fold(s). The tissue anchor(s) may be disposed through themuscularis and/or serosa layers of the gastrointestinal lumen.

The delivery device 208 shown in FIG. 3 generally comprises a tissuemanipulation assembly 210 and a needle deployment assembly 260. Thetissue manipulation assembly 210 is also shown in FIG. 4. The tissuemanipulation assembly 210 includes a flexible catheter or tubular body212 which is configured to be sufficiently flexible for advancement intoa body lumen, e.g., transorally, percutaneously, laparoscopically, etc.The tubular body 212 is configured to be torqueable through variousmethods, e.g., utilizing a braided tubular construction, such that whena handle 216 is manipulated and/or rotated by a practitioner fromoutside the patient's body, the longitudinal and/or torquing force istransmitted along the body 212 such that the distal end of the body 212is advanced, withdrawn, or rotated in a corresponding manner.

For example, in some embodiments, the tubular body 212 has a compositeconstruction that includes a first layer or multiple layers of braidedwire or mesh and a second layer or multiple layers of a polymericmaterial such as polyurethane, nylon, polyester, Pebax (polyether blockamide), or the like. An optional inner liner of polytetraflouroethylene(PTFE) may be provided to seal and/or to improve frictioncharacteristics. The physical properties (e.g., hardness, stiffness) ofa composite construction tubular body 212 will vary depending upon thematerials used, the specific construction, and other factors.

In some embodiments, the tubular body 212 includes a proximal sectionhaving a first hardness and/or stiffness, and a distal section having asecond hardness and/or stiffness that is lower than the hardness and/orstiffness of the proximal section. In these embodiments, the proximalsection corresponds with a portion of the tubular body 212 thattraverses a relatively non-tortuous path (e.g., through the relativelystraight esophagus), and the distal section corresponds with a portionof the tubular body 212 that traverses a relatively tortuous path (e.g.,bending regions of the tubular body or endoscopic access device that areguided or steered to reach portions of the stomach, colon, peritoneum,etc.). In this way, the tubular body 212 provides improvedmaneuverability during deployment, either as a standalone instrument oras deployed through a channel of an endoscopic access device. Inparticular, a distal section having a relatively lower hardness and/orstiffness will provide an improved capability to be rotated around itslongitudinal axis within the channel of an endoscopic access device incomparison to a distal section having a relatively higher hardnessand/or stiffness.

In a preferred embodiment, the proximal and distal sections are eachformed as composite tubes including an inner liner of PTFE, a layer ofstainless steel wire braid, and a layer of Pebax block copolymer. Theproximal section includes a braid wire formed from round wire having adiameter of from about 0.004″ to about 0.008″ and having from about 30picks per inch (“ppi”) to about 60 ppi, and a layer of Pebax having aShore D hardness of from about 30 to about 45, and/or a flexural modulus(ASTM D 790) of from about 72 MPa to about 87 MPa. The distal sectionincludes a braid wire formed from round wire having a diameter of fromabout 0.004″ to about 0.008″ and having from about 45 ppi to about 75ppi, and a layer of Pebax having a Shore D hardness of from about 20 toabout 35, and/or a flexural modulus (ASTM D 790) of from about 15 MPa toabout 28 MPa. Those skilled in the art will recognize that othercombinations of materials, material properties, and constructions of thetubular body 212 are possible. Moreover, those skilled in the art willrecognize that sections additional to the proximal section and distalsection may be added, with each section having different performancecharacteristics, in order to obtain desired performance.

A tissue manipulation end effector 214 is located at the distal end ofthe tubular body 212 and is generally used to contact and form tissuefolds and/or to otherwise bring portions of tissue into apposition. Theend effector is also shown in FIGS. 5A and 5B. The tissue manipulationend effector 214 is connected to the distal end of the tubular body 212via a pivotable coupling 218. A lower jaw member 220 extends distallyfrom the pivotable coupling 218 and an upper jaw member 222, in thisexample, is pivotably coupled to the lower jaw member 220 via a jawpivot 226. The location of the jaw pivot 226 may be positioned atvarious locations along the lower jaw 220 depending upon a number offactors, e.g., the desired size of the “bite” or opening for acceptingtissue between the jaw members, the amount of closing force between thejaw members, etc. One or both jaw members 220, 222 may also have anumber of protrusions, projections, grasping teeth, textured surfaces,etc. on the surface or surfaces of the jaw members 220, 222 facing oneanother to facilitate the adherence of tissue between the jaw members220, 222.

Turning to FIGS. 41A-C and 42A-D, two additional embodiments of thetissue manipulation end effector 214 are shown. For clarity, the tubularbody 212 and launch tube 228 are not shown in the drawings. In theembodiment shown in FIGS. 41A-C, the upper jaw 222 is pivotably coupledto the lower jaw 220 via a jaw pivot 226 that is fixedly attached to thelower jaw 220, as described above in relation to FIGS. 5A-B. In theembodiment shown in FIGS. 42A-D, a slotted jaw construction includes ajaw pivot 226 that is able to slide within an upright slot 232 formed inthe frame of the lower jaw 220. In an alternative embodiment not shown,the jaw pivot 226 is fixed to the lower jaw 220 and slides within a slot232 formed on the frame of the upper jaw 222. The capability of the jawpivot 226 to slide within the upright slot 232 provides the end effector214 with adjustable jaw geometries to better accommodate tissue folds(or other targets) having a wider range of sizes. For example, as shownby the illustrations in FIGS. 43A-B, the end effector 214 embodimenthaving the upright slot 232 (shown in FIG. 43B) is able to accommodate acomparably-sized target having a size “D” located at the vertex betweenthe upper jaw 222 and lower jaw 220 without having to be opened aswidely “W” as is necessary with the end effector 214 embodiment thatdoes not have the upright slot (shown in FIG. 43A).

Those skilled in the art will recognize that the slotted jawconstruction described above and shown in FIGS. 42A-D and 43B isadaptable for use in other endoscopic instruments (or non-endoscopicinstruments) having a pair of jaws oriented to grasp, trap, or engagetissue or other materials between the jaws. For example, the slotted jawconstruction may be adapted for use with an endoscopic stapling devicein order to provide improved orientation between an upper staplecartridge and a lower anvil portion of the device. Other uses of theslotted jaw construction are also possible.

Returning to FIGS. 3-7, a launch tube 228 extends from the handle 216,through the tubular body 212, and distally from the end of the tubularbody 212 where a distal end of the launch tube 228 is pivotallyconnected to the upper jaw member 222 at a launch tube pivot 230. Adistal portion of the launch tube 228 may be pivoted into positionwithin a channel or groove defined in upper jaw member 222, tofacilitate a low-profile configuration of tissue manipulation endeffector 214. When articulated, either via the launch tube 228 or othermechanism, the jaw members 220, 222 may be urged into an openconfiguration to receive tissue in the opening between the jaw members220, 222. (See, e.g., FIG. 5B).

The launch tube 228 may be advanced from its proximal end at the handle216 such that the portion of the launch tube 228 that extends distallyfrom the body 212 is forced to rotate at a hinge or pivot 230 andreconfigure itself such that the exposed portion forms a curved orarcuate shape that positions the launch tube opening perpendicularlyrelative to the upper jaw member 222. (See, e.g., FIG. 5A). The launchtube 228, or at least the exposed portion of the launch tube 228, may befabricated from a highly flexible material or it may be fabricated,e.g., from Nitinol tubing material which is adapted to flex, e.g., viacircumferential slots, to permit bending.

For example, turning to FIGS. 37, 38A-C, 39A-C, and 40A-B, fourembodiments of a flexible distal portion 238 of a launch tube 228 areshown. In the first embodiment, shown in FIG. 37, a plurality ofsubstantially uniformly spaced circumferential slots 240 are formed overthe distal portion 238. In the embodiment, each of the circumferentialslots 240 is of a substantially uniform length, with each extendingradially around greater than 50% of the circumference of the launchtube. In some embodiments, the circumferential slots extend radiallyaround the circumference of the launch tube by up to about 85% of thecircumference and, in still other embodiments, the circumferential slotsextend around the launch tube by up to about 90% of the circumference. Aspine 242—i.e., the unslotted longitudinal section of the distal portion238 of the launch tube—is defined along the length of the distal portion238. In some embodiments, the spine has a width of between about 10% toabout 15% or more of the circumference of the launch tube. As shown inFIG. 37, the size, shape, pattern, and orientation of thecircumferential slots 240 and the spine 242 cause the distal portion 238to flex and to effectively lock out at a predetermined position when adistally-oriented force is applied to the proximal end of the launchtube 228. The material, diameter, and wall thickness of the distalportion 238 of the launch tube also contribute to the degree of flex andpredetermined lock out position. The predetermined lock-out positionprovides a relatively high degree of planar stability to the distalregion 238 of the launch tube when it is in the flexed condition.

The launch tube distal region 238 embodiment shown in FIGS. 38A-Cincludes two regions 238 a, 238 b, each having a plurality ofcircumferential slots 240 formed in a pattern different from the other.In the first region 238 a, located near the distal end of the distalportion 238, the circumferential slots include an alternating patternincluding adjacent pairs of central semi-circumferential slots 244centered upon the bending radius of the launch tube distal region 238.Each adjacent pair of central semi-circumferential slots 244 isseparated by a pair of outer semi-circumferential slots 246. Each of thecentral slots 244 and outer slots 246 has a length of slightly less than50% of the circumference of the distal region 238 of the launch tube.The resulting pattern is substantially in the form of a repetition oftwo longitudinally-aligned central slots 244 following by two radiallyaligned outer slots 246 along the length of the first region 238 a. Inthe second region 238 b, located just proximally of the first region 238a, the circumferential slots include a right-angle zigzag pattern 248including nine adjoining segments each defining a right angle with itsadjoining sections. The right-angle zigzag pattern 248 defines aplurality of longitudinally aligned keyed segments 250 on each side ofthe central bending radius of the launch tube distal region 238. Thekeyed segments 250 serve an additional function of substantiallyinhibiting over-extension in the reverse direction of the predeterminedbending position, which may permanently deform or otherwise damage thedistal region 238 of the launch tube.

Turning next to FIGS. 39A-C, the launch tube distal region 238 shownthere includes a first region 238 a having the identical circumferentialslot pattern described above in relation to the first region 238 a ofthe launch tube shown in FIGS. 38A-C, including central slots 244 andouter slots 246. The second region 238 b includes slots defining amodified zigzag pattern 252 that includes at least two diagonal segmentsof the nine slot segments making up the modified zigzag pattern. Themodified zigzag pattern 252 defines a plurality of longitudinallyaligned keyed segments 254 on each side of the central bending radius ofthe launch tube distal region 238. The keyed segments 254 serve anadditional function of substantially inhibiting over-extension in thereverse direction of the predetermined bending position, which maypermanently deform or otherwise damage the distal region 238 of thelaunch tube.

Finally, turning to FIGS. 40A-B, the launch tube distal region 238 shownthere includes a first region 238 a also having the identicalcircumferential slot pattern described above in relation to the firstregion 238 a of the launch tube embodiments shown in FIGS. 38A-C and39A-C, including central slots 244 and outer slots 246. The secondregion 238 b also includes alternating central slots 244 and outer slots246, but the alternating pattern includes slots that are spaced furtherapart longitudinally as the pattern progresses toward the proximal end.A representative example of the pattern spacing is shown in FIG. 40B, inwhich the relationships between the illustrated dimensions area<b<c<d<e.

In the embodiments described above, a distal end of the launch tube 228is pivotally connected to the upper jaw member 222 at a launch tubepivot 230. The launch tube pivot 230 is pivotable around an axis definedby a pin that is attached to the upper jaw member 222 and that extendsthrough a hole in the pivot 230. In several other embodiments, shown inFIGS. 45A-B through 48A-B, an alternative pivot 630 is provided that iscapable of ranges of motion in addition to pivoting relative to theupper jaw member 222. For example, FIGS. 45A-B through 48A-B showalternative embodiments of an end effector 614 that includes a lowerbail 620 having a distal slot 621 and an upper bail 622 having a distalslot 623. The lower bail 620 and upper bail 622 are maintained in afixed spatial relationship relative to one another and are connected tothe tubular body 212 by a pivotable coupling 618. A helical grasper 640having a tissue piercing tip is movably retained within a slider 642that slides in a slot 644 formed in the lower fixed bail 620. Thehelical grasper 640 includes a shaft 641 that extends proximally to thehandle 216 of the anchor delivery device 208, where it is actuable bythe user. (See also FIGS. 50A-B). The helical grasper 640 is able to bemoved proximally and distally under the control of the user, as guidedby the slider 642. In this way, the helical grasper 640 may be used tograsp tissue and retract the tissue into the space defined between thelower fixed bail 620 and the upper fixed bail 622.

A pivot 630 is pivotably and slidably connected to the upper fixed bail622 via a pair of pivot pins 624 a, 624 b that are formed on the upperfixed bail 622. The pivot pins 624 a, 624 b are formed on opposing sidesof a slot defined by the upper fixed bail 622, and define a pivot axisabout which the pivot 630 is able to rotate. In a first embodiment,shown in FIGS. 45A-B and 47A-B, the pivot 630 includes two pivot slots632 formed on opposite sides of the external surface of the pivot. Eachpivot slot 632 has an elongated shape defined by a pivot slot upper end633 and a pivot slot lower end 634. The pivot 630 has a width that isslightly less than the width of the slot defined in the upper fixed bail622. Accordingly, the pivot pins 624 a, 624 b are able to reside withinthe spaces defined by the pivot slots 632 formed on each side of thepivot 630. In this way, the pivot 630 is able to rotate (pivot) aroundthe axis defined by the pivot pins 624 a, 624 b, and the body of thepivot 630 is also able to slide relative to the axis defined by thepivot pins 624 a, 624 b a distance defined by the length of the pivotslots 632. In this way, the pivot 630 may be rotated around the axisdefined by the pivot pins 624 a, 624 b, and/or the pivot 630 may bemoved into and out of the space between the lower fixed bail 620 andupper fixed bail 622 and/or proximally and distally relative to axisdefined by the pivot pins 624 a, 624 b (depending upon the orientationof the pivot 630 relative to the upper fixed bail 622).

In another embodiment, shown in FIGS. 48A-B, the pivot 630 includes apivot slot 636 having a generally triangular shape defined by a pivotslot upper corner 637, a pivot slot lower corner 638, and a pivot slotdistal corner 639. The generally triangular shape of the pivot slot 636allows additional ranges of motion enabled by the shape of the pivotslot 636. In addition, the triangular shape of the pivot slot 636 causesthe pivot 630 to be biased toward or into the space defined between thelower fixed bail 620 and upper fixed bail 622 (i.e., “downward” relativeto the views shown in FIGS. 48-B) when the launch tube 228 is withdrawnproximally (i.e., toward the handle 216) relative to the upper fixedbail 622. This biased motion results from the position of the distalcorner 639 that is located distally of the lower corner 638—i.e., as thelaunch tube 228 moves proximally relative to the upper fixed bail 622,the pivot pins 624 a, 624 b slide along the internal surface of the slot636 extending between the lower corner 638 and the distal corner 639until further movement is prevented.

Returning again to FIGS. 3-7, once the tissue has been engaged betweenthe jaw members 220, 222 (or the fixed bails 620, 622), a needledeployment assembly 260 is urged through the handle 216, though thetubular body 212, and out through the launch tube 228. The needledeployment assembly 260 may pass through the lower jaw member 220 via aneedle assembly opening (not shown in the drawing) defined in the lowerjaw member 220 to pierce through the grasped tissue. Once the needledeployment assembly has been passed through the engaged tissue, one ormore tissue anchors of a tissue anchor assembly 48 (see FIG. 7) aredeployed for securing the tissue, as described in further detail hereinand in U.S. patent application Ser. No. 10/955,245, which has beenincorporated by reference above.

FIG. 6 shows additional details relating to the needle deploymentassembly 260. As mentioned above, a needle deployment assembly 260 maybe deployed through the tissue manipulation assembly 210 by introducingneedle deployment assembly 260 into the handle 216 and through thetubular body 212, as shown in the assembly view of FIG. 3, such that theneedle assembly 266 is advanced from the launch tube and into or throughapproximated tissue. Once the needle assembly 266 has been advancedthrough the tissue, the anchor assembly 48 may be deployed or ejected.The anchor assembly 48 is normally positioned within the distal portionof a tubular sheath 264 that extends from a needle assembly control orhousing 262. Once the anchor assembly 48 has been fully deployed fromthe sheath 264, the spent needle deployment assembly 260 may be removedfrom the tissue manipulation assembly 210 and another needle deploymentassembly may be introduced without having to remove the tissuemanipulation assembly 210 from the patient. The length of the sheath 264is such that it may be passed entirely through the length of the tubularbody 212 to enable the deployment of the needle assembly 266 into and/orthrough the tissue.

The elongate and flexible sheath or catheter 264 extends removably fromthe needle assembly control or housing 262. The sheath or catheter 264and the housing 262 may be interconnected via an interlock 270 which maybe adapted to allow for the securement as well as the rapid release ofthe sheath 264 from the housing 262 through any number of fasteningmethods, e.g., threaded connection, press-fit, releasable pin, etc. Theneedle body 272, which may be configured into any one of the variationsdescribed above, extends from the distal end of the sheath 264 whilemaintaining communication between the lumen of the sheath 264 and theneedle opening 274.

An elongate pusher 276 comprises a flexible wire or hypotube that istranslationally disposed within the sheath 264 and movably connectedwithin the housing 262. A proximally-located actuation member 278 isrotatably or otherwise connected to the housing 262 to selectivelyactuate the translational movement of the elongate pusher 276 relativeto the sheath 264 for deploying the anchors from the needle opening 274.The tissue anchor assembly 48 is positioned distally of the elongatepusher 276 within the sheath 264 for deployment from the sheath 264.Needle assembly guides 280 protrude from the housing 262 for guidancethrough the locking mechanism described above.

In several embodiments, the delivery device 210 and needle deploymentassembly 260 are advanced into the gastrointestinal lumen using anendoscopic or endolumenal access system such as those described in theUnited States Patent Applications referenced above in Table 1. Examplesof endoscopic and endolumenal access systems 290 are shown in FIGS. 8Aand 8B. The endoscopic or endolumenal access systems 290 illustrated inFIGS. 8A and 8B each include a control mechanism 291 and a multi-lumen,steerable overtube 292 having several features that are described morefully in U.S. patent application Ser. Nos. 11/750,986 and 12/061,591,which were incorporated by reference above.

Turning to FIGS. 9-20, an embodiment of an actuator mechanism 70 for atissue anchor delivery device 208 is shown. The actuator mechanism 70comprises an alternative embodiment to the handle 216 described above inrelation to FIGS. 3 and 4. In the embodiment shown, the actuatormechanism 70 is configured to actuate both the tissue manipulationassembly 210 and the needle deployment assembly 260 independently of oneanother in order to grasp tissue and deploy a tissue anchor assembly 48in separate steps.

Turning first to FIG. 9, the illustrated actuator mechanism 70 includesa main housing 72 and a handle body 74 that is pivotably attached to themain housing by a hinge pin 76, such that a user is able to grasp themain housing 72 and handle body 74 in one hand and actuate the mechanismby pulling the handle body 74 toward the main housing 72. A linkage arm78 is interposed between the main housing 72 and the handle body 74, asdiscussed in more detail below. A nose cone 80 is attached to the distalend of the main housing 72 and surrounds the proximal end 82 of thetubular body 212.

In the embodiment shown, the proximal end 82 of the tubular body 212 isformed of a rigid material such as a rigid polymer material or stainlesssteel tubing. The remainder of the tubular body 212 is flexible and isformed of materials used to form the insertion portion of endoscopes andendoscopic devices. In alternative embodiments, the tubular body portionis formed of a composite tube that includes one or more polymericmaterials (e.g., Pebax) and one or more braided layers (e.g., stainlesssteel or polymeric braid) to provide the tubular body 212 with improvedtorque transmission and resistance to stretching.

A needle deployment assembly actuation mechanism 90 includes a needlelaunch bushing 92, a needle launch button 94, and a needle launch track96. The needle launch track 96 includes a plurality of substantiallyequally spaced, scallop-shaped cutouts 98 formed along the length of thetrack 96. More details of the structure and function of the needledeployment assembly actuation mechanism 90 is provided below.

FIGS. 10 and 11 show additional details concerning the structure andoperation of the actuator mechanism 70. The linkage arm 78 is pivotablymounted to the main housing 72 by a linkage arm pivot pin 102, aboutwhich the linkage arm 78 is able to rotate. The linkage arm 78 includesa hub portion 78 a, a drive arm 78 b extending from the hub 78 asubstantially toward the central portion of the main housing 72, and ahandle arm 78 c extending from the hub 78 a substantially toward thehandle body 74. In the embodiment shown, the drive arm 78 b and thehandle arm 78 c connecting through the hub portion 78 a define an acuteincluded angle, i.e., a “V”-shape. A handle body pin 104 is mounted onand extends from the handle body 74 through a handle arm slot 106 formedon the handle arm 78 c. A drive bushing pin 108 is mounted on a drivebushing 120 and extends from the drive bushing 120 through a drive armslot 110 formed on the drive arm 78 b.

The drive bushing 120 resides in a drive channel 122 formed in the mainhousing 72. More particularly, the external size and shape of the drivebushing 120 closely matches the internal size and shape of the drivechannel 122 such that the drive bushing 120 is able to slide through thedrive channel 122 along the longitudinal axis of the main housing 72.The drive bushing 120 is attached to (or formed integrally with) theproximal end of the launch tube 228, which extends through the drivechannel 122 and the tubular body 212 to the end effector 214, asdescribed above in relation to FIGS. 4 and 5A-B. In the embodimentshown, the drive bushing 120 and the proximal portion of the launch tube228 (e.g., the portion of the launch tube extending through the drivechannel 122 in the main housing 72) each includes an upward-facingopening defining a loading channel 124 for receiving and retaining aneedle deployment catheter, as described more fully below.

During operation, as the handle body 74 is moved toward the main housing72 (by rotating the handle body 74 around the hinge pin 76), the handlebody pin 104 causes the linkage arm 78 to rotate counterclockwise (asviewed in FIG. 11), thereby driving the drive bushing 120 toward thedistal end of the device (i.e., toward the left as viewed in FIG. 11).This action causes the launch tube 228 to translate distally, e.g., fromthe jaws open position illustrated in FIG. 5B to the jaws closed andlaunch tube pivoted position illustrated in FIG. 5A. In this way, theaction of squeezing the handle body 74 toward the main housing 72 causesthe actuation mechanism 70 to actuate the launch tube 228 which actioncauses the lower jaw 220 and upper jaw 222 of the end effector 214 tograsp and manipulate tissue. The squeezing action also causes theportion of the launch tube 228 that extends distally from the tubularbody 212 to rotate at the hinge or pivot 230 and reconfigure itself suchthat the exposed portion forms a curved or arcuate shape that positionsthe launch tube opening substantially perpendicularly relative to theupper jaw member 222. (See, e.g., FIG. 5A). This position facilitatesdelivery of the anchor assembly 48, as described above and below.

The actuation mechanism 70 embodiment shown in the drawings alsoincludes a handle lock mechanism 130 that is configured to maintain theposition of the handle body 74 relative to the main housing 72 at one ormore positions during operation of the actuation mechanism 70. Thehandle lock mechanism 130 is illustrated in FIGS. 12A-G, which representseveral positions of the handle lock mechanism that occur during asingle cycle of the actuation mechanism 70. The handle lock mechanism130 includes a stationary pin 132 that is fixed to (or formed integrallywith) the main housing 72, and a locking pin 134 that is neither fixedto nor formed integrally with the main housing 72. A locking pin spring136 is connected at one end to the stationary pin 132 and at its otherend to the locking pin 134, thereby providing a force biasing thelocking pin 134 toward the location of the stationary pin 132. Thelocking pin 134 extends through a locking pin slot 112 formed throughthe drive arm 78 b between the hub 78 a and the drive arm slot 110. Thelocking pin slot 112 includes and outer portion 112 a and an innerportion 112 b, with a ledge 112 c located at the transition between theouter portion 112 a and the inner portion 112 b.

In the embodiment shown, the handle lock mechanism 130 also includes alocking pin track 138. The locking pin track 138 comprises a set ofgrooves and raised surfaces formed on at least one of the inner facingsurfaces of the main housing 72. The locking pin 134 extends into one ormore of the grooves defined by the locking pin track 138 such that thetrack 138 limits the movement of the locking pin 134. In the illustratedembodiment, the track 138 includes an upper groove 140, a distal groove142, and a lower groove 144. Together, the upper groove 140, distalgroove 142, and lower groove 144 form a substantially triangular shapein which each of the grooves is connected at a point to each of theother grooves. As described below, translation of the locking pin 134along and through the upper groove 140 corresponds with movement of thehandle body 74 toward the main housing 72 and, concurrently, movement ofthe launch tube 228 distally toward the end effector 214. Positioningthe locking pin 134 within the distal groove 142 corresponds with thejaws closed and launch tube pivoted and curved position illustrated inFIG. 5A. Finally, translation of the locking pin 134 along and throughthe lower groove 144 corresponds with movement of the handle body 74away from the main housing 72 and, concurrently, movement of the launchtube 228 proximally.

FIG. 12A shows a starting position of the locking mechanism 130 in whichthe drive arm 78 b is at its proximal-most position. The locking pin 134is positioned within the outer portion 112 a of the locking pin slot andis at the intersection of the upper groove 140 and lower groove 144. Asthe handle body 74 and main housing 72 are squeezed together, thelinkage arm 78 rotates counterclockwise (as shown in FIGS. 12A-G). Thismotion causes the drive arm 78 b to move the locking pin 134 generallydistally. The locking pin spring 136 provides a generally downward andproximal force (as shown in FIGS. 12A-G) on the locking pin 134, causingthe locking pin 134 to rest upon the ledge 112 c of the locking pinslot. The radial position of the ledge 112 c on the drive arm 78 bcauses the locking pin 134 to translate through the upper groove 140,rather than the lower groove 144, as the locking pin 134 traverses theintersection of the two grooves (see FIG. 12B) and beyond (see FIG.12C).

As the locking pin 134 traverses the upper groove 140, the rampedsurface of the upper groove biases the locking pin 134 radially outwardin the outer portion 112 a of the locking pin slot, i.e., away from theledge 112 c. Further squeezing of the handle body 74 and main housing 72causes the locking pin 134 ultimately to reach the distal slot 142, uponwhich the force of the locking pin spring 136 causes the locking pin 134to slide into the distal slot 142 until the locking pin 134 againencounters the ledge 112 c of the locking pin slot. (See FIG. 12D). Atthis point, the locking pin 134 is trapped between the edges of thelocking pin slot 112 of the linkage arm 78 and the distal slot 142 ofthe locking pin track 138, preventing any further rotation of the handlebody 74 relative to the main housing 72. As the user releases thesqueezing action on the handle body 74, the linkage arm 78 will rotateslightly in the clockwise direction (as shown in FIGS. 12A-G), releasingthe locking pin 134 from the ledge 112 c of the locking pin slot andinto a trough 143 formed in the distal groove, where it is retainedunder the force of the locking pin spring 136. (See FIG. 12E). Uponre-squeezing by the user of the handle body 74 relative to the mainhousing 72, the edge of the inner portion 112 b of the locking pin slotengages the locking pin 134, forcing the locking pin 134 out of thetrough 143 of the distal groove. The spring force of the locking pinspring 136 pulls the locking pin 134 downward from the distal groove 142into the intersection of the distal groove 142 with the lower groove144. (See FIG. 12F). As the handle body 74 is released by the user, thelinkage arm 78 rotates clockwise (as shown in FIGS. 12A-G) and thelocking pin 134 is allowed to traverse the lower groove 144 proximally(see FIG. 12G) until the locking pin 134 returns to the staringposition.

Those skilled in the art will recognize that the handle lock mechanism130 embodiment described herein may be modified to provide a range ofmovement different from that provided by the embodiment shown in orderto support other and different functions or processes to be performed bythe device associated with the actuator mechanism 70. For example, asingle cycle may include more or fewer grooves and intersections.Variations of other parameters and components are also possible.

Turning next to FIGS. 13A and 13B, another embodiment of a needledeployment assembly 150 is shown. The needle deployment assembly 150 isconfigured for use with the actuator mechanism 70 described above inrelation to FIGS. 9 through 12. The assembly 150 includes a rigid bodyportion 152 and a flexible catheter portion 154 extending distally fromthe distal end of the rigid body portion 152. A needle 156 is fixed tothe distal end of the catheter portion 154. The upper surface of therigid body portion 152 includes an elongated groove 158 that providesaccess into the generally tubular rigid body 152. A suture deploymentbutton 160 extends from the interior of the rigid body portion 152through the groove 158.

Additional details of the needle deployment assembly are shown in thecross-sectional views provided in FIGS. 14A-C. As shown there, thesuture deployment button 160 is attached via a screw to a suture wirebushing 162 that is concentrically and slidably retained within therigid body portion 152 of the assembly. The suture wire bushing 162 isattached to a suture wire 164 (e.g., nitinol, stainless steel, cable, orbraid) that extends through the rigid body 152 and the flexible catheter154. A pusher coil bushing 166 is also concentrically and slidablyretained within the rigid body portion 152 just distally of and, at theposition shown in FIG. 14A, abutting the suture wire bushing 162. Thepusher coil bushing 166 is attached to a pusher coil 168 that extendsthrough the rigid body 152 and the flexible catheter 154. In theembodiment shown, the pusher coil 166 is a coiled wire defining acentral lumen through which the suture wire 164 extends substantiallyconcentrically. A pusher coil bushing set screw 170 is attached to thepusher coil bushing 166 and extends upward through the groove 158 into arecess formed in the suture deployment button 160. An attachment post172 is formed on the proximal end of the rigid body 152.

Turning next to FIGS. 15A-C, the structure of the anchor assembly 48 isshown. The anchor assembly 48 includes a distal anchor 50 a, a proximalanchor 50 b, a suture 52, and a cinch 62. A knot 54 is formed at thedistal end of the suture 52. A proximal end of the suture 52 is attachedto a distal end of the suture wire 164 in a manner described below.

The operation of the needle deployment assembly 150 will now bedescribed. A starting point is shown in FIGS. 13A, 14A, and 15A, inwhich the suture deployment button is at its proximal-most extent. Asthe suture deployment button 160 is advanced distally, the suture wirebushing 162 and pusher coil bushing 166 are advanced distally, therebydriving the anchor assembly 48 distally until the anchor assembly 48exits the catheter body 152 through the needle 156. (See FIGS. 13B, 14B,15B). In an embodiment, the distal anchor 50 a and proximal anchor 50 bare advanced in separate steps, as described more fully below. Afterfull advancement, the pusher coil bushing set screw 170 may be locked inplace by moving the screw 170 into a detent (not shown) located at adistal end of the groove 158, thereby fixing the pusher coil 168 inplace relative to the other components of the assembly. In oneembodiment, the detent comprises a narrowed region of the groove 158that provides a snug press-fit for the screw 170. Other detentmechanisms are also possible. Next, the suture deployment button 160 isretracted proximally, whereby the suture wire 164 is retracted as thepusher coil 168 is fully extended. The distal end of the pusher coil 168has a diameter that substantially matches up with the diameter of thecinch 62, whereby the pusher coil 168 prevents proximal movement of thecinch 62 and any of the components retained on the suture 52 on thedistal side of the cinch 62. As the knot 64 engages the distal portionof the distal anchor 50 a, further retraction of the button 160 causesthe anchors 50 a, 50 b to transition to their expanded deployment state.(See FIGS. 14C, 15C, and 16A-B).

In the embodiment shown, the anchor assembly 48 includes a breakawayfeature that facilitates separation of the anchor assembly 48 from thesuture wire 164, thereby providing the ability to deposit the anchorassembly 48 and separate it from the delivery device without the need tocut the suture 52. As shown in FIG. 16B, a junction 176 is formedbetween the suture wire 164 and the suture 52. In the embodiment, one ormore layers of shrink wrap 178 are applied over the junction and affixedto both the suture wire 164 and the suture 52, thereby bonding the twotogether. The shrink wrap 178 creates a slight “bump,” or an in thethicknesses of the suture 52 and the suture wire 164 where it is appliedover the suture 52 and suture wire 164. In the embodiment shown, theincreased thickness provided by the “bump” causes an increase in thepushing force needed to cause an anchor 50 a, 50 b or a cinch 62 to passover the junction 176, but it does not prevent passage of thesecomponents. Moreover, the shrink wrap 178 has sufficient tensilestrength to support the cinching procedure described above, while stillproviding the ability to pull the junction apart upon applying arelatively small tensile load on the suture wire 168.

As a result, in operation, the added thickness provided by the layer ofshrink wrap 178 causes the distal anchor 50 a to remain stationary onthe suture 52 while the anchor 50 a is being advanced out of the needle156 in its low profile state during delivery, (see, e.g., FIG. 17),while still allowing the user to advance the anchor 50 a over the suture52 under the force provided by the pusher coil 168 when desired duringdeployment. Similarly, the proximal anchor 50 b and cinch 62 aregenerally maintained in a fixed position on the suture wire 164 spacedapart from the distal anchor 50 a during delivery. In addition, theincreased rigidity and column strength of the suture wire 164 relativeto the suture 52 provides the ability to advance the anchor assembly 48out of the needle deployment assembly 150 in a controlled manner.

Those skilled in the art will appreciate that other breakaway featuresor suture cutting devices and methods may be suitable for separating theanchor assembly 48 from the delivery device. For example, several suturecutting devices suitable for use with the anchor delivery devicesdescribed herein are described in U.S. patent application Ser. No.11/412,261, filed Apr. 26, 2006, which is hereby incorporated byreference in its entirety. In addition, several embodiments of a cuttingdevice for cutting the suture of an anchor assembly 48 after deploymentare shown in FIGS. 49 through 54A-B. For example, FIGS. 49 and 52A-Bshow an embodiment of an end effector 214 as described previously. Thisembodiment includes a pivot 230 within which or on which a cutting blade650 is disposed. The cutting blade 650 is located at or near the distalend of the pivot 230 and is oriented to face generally toward the distalend of the device. In the embodiment shown, the cutting blade 650 has agenerally cylindrical shape and is attached, connected to, or formedintegrally with the internal surface of the generally cylindrical pivot230. The distal end of the pivot 230 extends distally of the distal endof the cutting blade 650—i.e., the edge of the cutting blade 650 isgenerally shielded by the distal end of the pivot 230. The distal end ofthe pivot 230 includes at least one slot 652 that provides access to thecutting edge of the cutting blade 650. For example, the embodimentsshown in FIGS. 49 and 52A-B include three slots 652, two of which arelocated on opposite sides of the pivot 230 and a third locatedequidistant between the first two along the upper side of the pivot 230.In the embodiments shown, each slot 652 includes a narrowed opening 654that is wide enough to accommodate the suture 52 of the anchor assembly48. In addition, the distal surfaces of the pivot 230 may be tapered inorder to guide the suture 52 into the narrowed opening 654 and into theslot 652 where the suture may be engaged by the cutting edge of thecutting blade 650.

FIGS. 50A-B and 51 show the alternative embodiment of the end effector614 described above in relation to FIGS. 45A-B through 48A-B. The endeffector 614 is provided with a pivot 230 having a cutting blade 650 andone or more slots 652 and narrowed openings 654, as described herein.

Additional details of the pivot 230 and cutting blade 650 are shown inFIGS. 53A-B and 54A-B. In the embodiments shown, the pivot 230 includesa through-hole 231 through which a pin (not shown) extends. The pin, inturn, is attached to opposed sides of an upper jaw member 222 or upperfixed bail 622, and enables the pivot 230 to rotate about an axisdefined by the pin. A cutting blade 650 having a distal-facing cuttingedge is attached to the internal surface of the pivot 230 such that thecutting edge of the cutting blade 650 is located within the spacedefined by a slot 652 formed on the pivot 230. (See FIGS. 53B and 54B).A narrowed opening 654 provides access to the slot 652. The distal endsof the pivot 230 are provided with tapered surfaces 655 that lead towardthe narrowed opening 654. The embodiment shown in FIGS. 53A-B includesonly a single slot 652 and narrowed opening 654 providing access to thecutting blade 650. In the embodiment shown in FIGS. 54A-B, three slots652 and narrowed openings 654 are provided. Those skilled in the artwill appreciate that fewer or more slots 652 and narrowed openings 654may be included to achieve desired results.

To operate the cutting devices shown in FIGS. 49 through 54A-B, the userdeploys an anchor assembly 48 in the manner described herein. Afterdeployment, and while the suture 52 extends from the anchor assembly 48to the anchor deployment device 208, the user manipulates the endeffector 214 to cause the suture 52 to move through a narrowed opening654 and into one of the slots 652, where it engages the cutting edge ofthe cutting blade 650. The user then manipulates the tissue manipulationassembly 210 and the anchor assembly 48 so as to cause the cutting edgeof the cutting blade 652 to sever the suture 52, thereby releasing theanchor assembly 48 from the device.

Turning next to FIG. 18, additional details of the structure andoperation of the needle deployment assembly actuation mechanism 90 areshown. As described above in relation to FIGS. 9-11, the mechanismincludes a needle launch bushing 92 that is slidably retained within thedrive channel 122 of the main housing 72, a needle launch track 96 thatis fixed to the main housing 72 above the drive channel 122, and aneedle launch button 94. The launch track 96 defines a channel 97 inwhich the button 94 is able to slide longitudinally under control of theuser. The button 94 includes a base portion 94 a and a top portion 94 bthat are attached to each other, with the base portion 94 a slidingwithin the launch track channel 97 and the top portion 94 b extendingabove the launch track 96 to be accessible to the user. In theembodiment shown, the base portion 94 a and top portion 94 b of thebutton 94 are attached by a tab and slot mechanism, although otherattachment mechanisms are also suitable. A needle lock leaf spring 99 ispositioned within the button 94. The leaf spring 99 includes a lockingtab 99 a that extends through a leaf spring slot 95 formed in the baseportion 94 a of the button.

The locking tab 99 a is biased outward through the leaf spring slot 95to engage one of the cutouts 98 formed on the needle launch track 96.When the locking tab 99 a is engaged in one of the cutouts 98, the leafspring 99 prevents the needle launch button 94 from moving along theneedle launch track 96. By applying a lateral (longitudinally-directed)force on the top portion 94 b of the button, the user is able to biasthe leaf spring locking tab 99 a inward, away from the launch track 96,thereby disengaging the tab 99 a from a cutout 98 and allowing the userto slide the needle launch button 94 within the launch track channel 97.As shown in FIG. 11, the needle launch button 94 is attached by a screwto the needle launch bushing 92. In this manner, movement of the needlelaunch button 94 causes movement of the needle launch bushing 92 withinthe drive channel 122. In the embodiment shown, this movement of theneedle launch bushing 92 is independent of any movement of the drivebushing 120.

Turning next to FIG. 19, the needle deployment assembly 150 is shownbeing loaded into the actuator mechanism 70. The loading procedureincludes inserting the distal end of the needle deployment assembly 150(i.e., the needle body 156) into the loading channel 124 and directingthe needle body 156 and flexible catheter body 154 distally through thelumen defined by the launch tube 228 extending through the tubular body212. After the rigid body portion 152 is loaded into the loading channel124, a detent mechanism on the needle launch bushing 92 is rotated tofixedly engage the attachment post 172 on the rigid body 152, therebyattaching the needle deployment assembly 150 to the needle launchbushing 92. In this manner, movement of the needle launch bushing 92within the drive channel 122 causes movement of the needle deploymentassembly 150 relative to and concentrically within the launch tube 228.

FIG. 20 shows a cross-sectional view of the rigid proximal portion 82 ofthe tubular body 212 extending from the distal end of the main housing72. FIG. 20 shows the device prior to loading a needle deploymentassembly 150. A distal shoulder 83 is defined on the interior of thetubular body 212 at the point of transition between the rigid proximalportion 82 and the flexible portion of the tubular body 212. The distalend of a launch tube spring 84 rests against the shoulder 83 in theannular space between the rigid proximal portion 82 of the tubular bodyand the launch tube 228. A needle deployment assembly loading sleeve cap85 comprises a transition point between a larger diameter portion of thelaunch tube 228 a near the proximal end of the device and a smallerdiameter portion of the launch tube 228 b extending distally through theflexible tubular body 212. The loading sleeve cap 85 defines a proximalshoulder 86 against which the proximal end of the launch tube spring 84abuts. In this manner, when the launch tube 228 is advanced distally,the launch tube spring 84 is compressed between the distal shoulder 83and the proximal shoulder 86. The spring force of the launch tube spring84 thereby provides a force biasing the launch tube 228 proximally. Thisproximally-directed spring force provides resistance against a forcesqueezing the handle body 74 against the main body 72, thereby biasingthe handle body 74 to the open position.

The spring force provided by the launch tube spring 84 also facilitatesthe operation of the handle lock mechanism 130 described above inrelation to FIGS. 12A-G. In particular, the proximally-directed springforce applied to the launch tube 228 is transferred to the locking pin134 through the drive bushing 120, drive bushing pin 108, and linkagearm 78. This force facilitates the movement of the locking pin 134proximally through the lower groove 144 during the return portion of thecycle, as shown in FIGS. 12F and 12G. As the locking pin 134 movesproximally within the lower groove 144, the ramped lower surface of thelower groove 144 causes the locking pin 134 also to move upward in theinner portion 112 a of the locking pin slot in order to return to thestarting position in which the locking pin 134 rests on the ledge 112 c,as shown in FIG. 12A.

The interior of the loading sleeve cap 85 defines a surface againstwhich the distal-most portion of the rigid body portion 152 of theneedle deployment assembly 152 abuts during loading of the assembly,while allowing passage of the flexible catheter portion 154 through thelumen defined by the launch tube 228.

The combined operation of the actuator mechanism 70 and needledeployment assembly 150 will now be described. As shown in FIG. 7, theend effector 214 is located at a point near a target region of tissue,at which point the jaws 220, 222 are opened under control of theactuator mechanism 70. After the tissue is placed between the jaws 220,222, the handle body 74 is squeezed toward the main housing 72, whichcauses the launch tube 228 to advance distally, closing the jaws 220,222 upon the tissue. The distal portion of the launch tube 228 is alsotransitioned to an arcuate shape in which the distal opening of thelaunch tube 228 is positioned substantially perpendicularly to thetissue grasped between the jaws 220, 222. At this point, the locking pin134 is positioned in the trough 143 of the distal groove 142, therebymaintaining the actuator mechanism 70 in a “closed” positioncorresponding with a closed position of the jaws 220, 222.

Once the tissue has been grasped and the launch tube 228 positioned asdescribed above, the needle launch button 94 is advanced distally withinthe launch track 96, thereby causing the needle deployment assembly 150to be advanced through the launch tube 228. The needle launch button 94is then locked in place by allowing the leaf spring 99 to engage one ofthe cutouts 98 of the needle launch track 96. The needle 156 pierces andextends through the tissue, as shown in FIG. 7. In an embodiment, thelength of travel allowed for the needle launch button 94 within thelaunch track 96 is such that the needle 156 is prevented from extendingpast a desired distance beyond the lower jaw 220. Once the needle 156 isin its proper position, the distal anchor 50 a is deployed by advancingthe suture deployment button 160 a distance sufficient to extend thedistal anchor 51 out of the needle 156 of the needle deployment assembly150, as shown in FIG. 7. The distal anchor 50 a is thereby deployed onthe distal side of the tissue fold held by the jaws 220, 222. In theembodiment shown, the length of travel allowed for the suture deploymentbutton within the loading channel 124 when the needle launch button 94is fully advanced is such that only the distal anchor 50 a is advancedout of the needle deployment assembly 150. After the distal anchor 50 ais deployed, the needle launch button 94 is retracted, therebyretracting the needle 156 from the tissue and into the launch tube 228.Retraction of the needle launch button 94 also causes the suturedeployment button 160 to be retracted within the loading channel 124.The jaws 220, 222 are disengaged from the tissue by squeezing andreleasing the handle body 74 and main housing 72. As a result, thesuture 52 extends through the tissue as the proximal anchor 50 b remainswithin the needle deployment assembly 150. The proximal anchor 50 b maythen be deployed.

As noted above, the action of retracting the needle launch button 94also retracts the suture deployment button 160 within the loadingchannel 124. Accordingly, the suture deployment button 160 is now ableto be advanced distally, causing the proximal anchor 50 b to be extendedoutside of the needle body 156 and the needle deployment assembly 150.(See, e.g., FIG. 13B). The proximal anchor 50 b is located on theproximal side of the tissue fold. At this point, the pusher coil bushingset screw 170 is locked in place, thereby locking in place the pushercoil bushing 166 and pusher coil 168. The needle deployment button 160is then withdrawn proximally, causing the suture wire 164 to bewithdrawn relative to and through the pusher coil 168. This actioncauses the suture 52 to be retracted proximally through the distalanchor 50 a, proximal anchor 50 b, and the cinch 62, thereby fullydeploying the anchor assembly 48. (See, e.g., FIGS. 14C, 15C, and16A-B). The anchor assembly 48 is thereby deployed to retain a tissuefold F, as shown schematically in FIG. 1B. Further retraction of thesuture deployment button 160 creates sufficient tensile stress on thesuture wire 164 to break the shrink wrap 178 at the junction 176,leaving a relatively short tail of suture 52 extending proximally of theproximal anchor 50 b.

Turning to FIGS. 21-36, another embodiment of an actuator mechanism 370for a tissue anchor delivery device 208 is shown. The actuator mechanism370 comprises another alternative embodiment to the handle 216 describedabove in relation to FIGS. 3 and 4 and the actuator mechanism 70described above in relation to FIGS. 9-20. In the embodiment shown, theactuator mechanism 370 is configured to actuate both the tissuemanipulation assembly 210 and the needle deployment assembly 260independently of one another in order to grasp tissue and deploy atissue anchor assembly 48 in separate steps. The actuator mechanism 370also includes a number of additional features that will be described inrelation to the Figures.

Turning first to FIGS. 21, 22A-B, and 44A-C, the illustrated actuatormechanism 370 includes a main housing 372 and a handle body 374 that ispivotably attached to the main housing by a hinge pin 376, such that auser is able to grasp the main housing 372 and handle body 374 in onehand and actuate the mechanism by pulling the handle body 374 toward themain housing 372. A linkage arm 378 is interposed between the mainhousing 372 and the handle body 374, as discussed in more detail below.A nose cone 380 is attached to the distal end of the main housing 372and surrounds the proximal end 82 of the tubular body 212.

In the embodiment shown in FIGS. 44A-C, the actuator mechanism 370includes several features that assist the user in gripping the deviceand utilizing the actuator mechanism. For example, the main housing 372includes a distal finger rest 373 located at the distal end of the mainhousing 372. The distal finger rest 373 comprises a raised surfaceformed on the underside of the main housing (i.e., the side of the mainhousing to which the handle body 374 is attached). The raised surface ofthe distal finger rest 373 defines a small pocket 373 a on the undersideof the main housing 372 at the location on the actuator mechanism 370upon which the user's index finger wraps around the main housing 372when the user is holding the mechanism in a “palm-down” orientation(i.e., palm on topside, fingers wrapped around underside, distal end ofthe actuator mechanism extending through the hand beyond the thumb andindex finger). In this way, the distal finger rest 373 provides the userwith additional tactile information and improved control over the tissuemanipulation assembly 210 when the user is holding the actuatormechanism in the “palm-down” orientation. In addition, the handle body374 includes a proximal finger rest 375 located near a proximal end ofthe handle body 374. The proximal finger rest 375 comprises a raisedsurface formed on the underside of the handle body 374 (i.e., the sidefacing away from the main housing 372). The raised surface of theproximal finger rest 375 defines a small pocket 375 a on the undersideof the handle body 374 at the location on the actuator mechanism 370upon which the user's index finger wraps around the handle body 374 whenthe user is holding the mechanism in a “palm-up” orientation (i.e., palmon underside, fingers wrapped around topside, distal end of the actuatormechanism extending through the hand beyond the little finger and theheel of the palm). In this way, the proximal finger rest 375 providesthe user with additional tactile information and improved control overthe tissue manipulation assembly 210 when the user is holding theactuator mechanism in the “palm-up” orientation.

During some forms of use of the tissue manipulation assembly 210, theuser will hold the actuator mechanism with a single hand in thepalm-down orientation in order to deploy the device to a treatmentlocation, and to operate the handle body 374. The user is then able toreposition the actuator mechanism 370 in the same hand to the palm-uporientation in order, for example, to operate the needle launch button394 and/or the suture deployment button 460 (as described below) withthe thumb of the same hand. The distal finger rest 373 and proximalfinger rest 375 facilitate these actions by providing support andtactile information during the respective procedures.

In the embodiment shown, the proximal end 82 of the tubular body 212 isformed of a rigid material such as a rigid polymer material or stainlesssteel tubing. The remainder of the tubular body 212 is flexible and isformed of materials used to form the insertion portion of endoscopes andendoscopic devices. In alternative embodiments, such as those describedpreviously, the tubular body portion is formed of a composite tube thatincludes one or more polymeric materials (e.g., Pebax) and one or morebraided layers (e.g., stainless steel or polymeric braid) to provide thetubular body 212 with improved torque transmission and resistance tostretching.

A needle deployment assembly actuation mechanism 390 includes a needlelaunch button 394, and a needle launch track 396. The needle launchtrack 396 includes a plurality of substantially equally spaced,scallop-shaped cutouts 398 formed along the length of the track 396.More details of the structure and function of the needle deploymentassembly actuation mechanism 390 are provided below.

FIGS. 23, 24, and 25A-B show additional details concerning the structureand operation of the actuator mechanism 370. The linkage arm 378 ispivotably mounted to the main housing 372 by a linkage arm pivot pin402, about which the linkage arm 378 is able to rotate. The linkage arm378 includes a hub portion 378 a, a drive arm 378 b extending from thehub 378 a substantially toward the central portion of the main housing372, and a handle arm 378 c extending from the hub 378 a substantiallytoward the handle body 374. In the embodiment shown, the drive arm 378 band the handle arm 378 c connecting through the hub portion 378 a definean acute included angle, i.e., a “V”-shape. A handle body pin 404 ismounted on and extends from the handle body 374 through a handle armslot 406 formed on the handle arm 378 c. A drive bushing pin 408 ismounted on a drive bushing 420 and extends from the drive bushing 420through a drive arm slot 410 formed on the drive arm 378 b.

The drive bushing 420 resides in and travels through a drive channel 422formed in the main housing 372. More particularly, the external size andshape of the drive bushing 420 closely matches the internal size andshape of the drive channel 422 such that the drive bushing 420 is ableto slide through the drive channel 422 along the longitudinal axis ofthe main housing 372. The drive bushing 420 is attached to (or formedintegrally with) the proximal end of the launch tube 228, which extendsthrough the drive channel 422 and the tubular body 212 to the endeffector 214, as described above in relation to FIGS. 4 and 5A-B. In theembodiment shown, the drive bushing 420 and the proximal portion of thelaunch tube 228 (e.g., the portion of the launch tube extending throughthe drive channel 422 in the main housing 372) each includes anupward-facing opening defining an actuation channel 424 providing apathway for passage of an actuator button of a needle deploymentcatheter, as described more fully below.

During operation, as the handle body 374 is moved toward the mainhousing 372 (by rotating the handle body 374 around the hinge pin 376),the handle body pin 404 causes the linkage arm 378 to rotatecounterclockwise (as viewed in FIG. 23), thereby driving the drivebushing 420 toward the distal end of the device (i.e., toward the leftas viewed in FIG. 23). This action causes the launch tube 228 totranslate distally, e.g., from the jaws open position illustrated inFIG. 5B to the jaws closed and launch tube pivoted position illustratedin FIG. 5A. In this way, the action of squeezing the handle body 374toward the main housing 372 causes the actuation mechanism 370 toactuate the launch tube 228 which action causes the lower jaw 220 andupper jaw 222 of the end effector 214 to grasp and manipulate tissue.The squeezing action also causes the portion of the launch tube 228 thatextends distally from the tubular body 212 to rotate at the hinge orpivot 230 and reconfigure itself such that the exposed portion forms acurved or arcuate shape that positions the launch tube openingsubstantially perpendicularly relative to the upper jaw member 222.(See, e.g., FIG. 5A). This position facilitates delivery of the anchorassembly 48, as described above and below.

The actuation mechanism 370 embodiment shown in the drawings alsoincludes a handle lock mechanism 430 that is configured to maintain theposition of the handle body 374 relative to the main housing 372 at oneor more positions during operation of the actuation mechanism 370. Thehandle lock mechanism 430 is illustrated in FIGS. 23, 25A, and 26A-B,which illustrate several positions of the handle lock mechanism thatoccur during a selected cycle of the actuation mechanism 370. The handlelock mechanism 430 includes a stationary pin 432 that is fixed to (orformed integrally with) the main housing 372, and a locking pin 434 thatis neither fixed to nor formed integrally with the main housing 372. Alocking pin spring (not shown for clarity) is connected at one end tothe stationary pin 432 and at its other end to the locking pin 434,thereby providing a force biasing the locking pin 434 toward thelocation of the stationary pin 432. The locking pin 434 extends througha locking pin slot 412 formed through the drive arm 378 b between thehub 378 a and the drive arm slot 410. The locking pin slot 412 includesand outer portion 412 a and an inner portion 412 b, with a ledge 412 clocated at the transition between the outer portion 412 a and the innerportion 412 b.

In the embodiment shown, the handle lock mechanism 430 also includes alocking pin track 438. The locking pin track 438 comprises a set ofgrooves and raised surfaces formed on at least one of the inner facingsurfaces of the main housing 372. The locking pin 434 extends into oneor more of the grooves defined by the locking pin track 438 such thatthe track 438 limits the movement of the locking pin 434. In theillustrated embodiment, the track 438 includes an upper track 440, aninner track 442, an outer track 444, and a lower track 446. Together,the upper track 440, inner track 442, outer track 444, and lower track446 form a substantially triangular shape in which each of the inner andouter tracks is operatively connected at an intersection to each of theupper and lower tracks. As described below, positioning the locking pin434 at the proximal end 447 of the upper track 440 corresponds with the“fully open position” in which the jaws of the end effector are open.(See FIG. 5B). From there, translation of the locking pin 434 along andthrough the upper track 440 corresponds with movement of the handle body374 toward the main housing 372 and, concurrently, movement of thelaunch tube 228 distally toward the end effector 214. Positioning thelocking pin 434 within the inner track 442 corresponds with placing thehandle in a “parked” or “neutral” position in which the jaws of the endeffector are closed, but the launch tube is not pivoted. (See, e.g.,FIG. 4). Positioning the locking pin 434 within the outer track 444corresponds with the fully closed position in which the jaws are closedand the launch tube pivoted and curved into the position illustrated inFIG. 5A. Finally, translation of the locking pin 434 along and throughthe lower track 446 corresponds with movement of the handle body 374away from the main housing 372 and, concurrently, movement of the launchtube 228 proximally.

FIG. 23 shows a starting position of the locking mechanism 430 in whichthe drive arm 378 b is at its proximal-most position. The locking pin434 is positioned within the outer portion 412 a of the locking pin slotand is at the fully open position 447 near the intersection of the uppertrack 440 and lower track 446. As the handle body 374 and main housing372 are squeezed together, the linkage arm 378 rotates counterclockwise(as shown in FIG. 23). This motion causes the drive arm 378 b to movethe locking pin 434 generally distally. The locking pin spring providesa generally downward and proximally-directed force (as shown in FIG. 23)on the locking pin 434, causing the locking pin 434 to rest upon theledge 412 c of the locking pin slot. The radial position of the ledge412 c on the drive arm 378 b causes the locking pin 434 to translatethrough the upper track 440, rather than the lower track 446, as thelocking pin 434 traverses the intersection of the two tracks and beyond.

As the locking pin 434 traverses the upper track 440, the ramped surfaceof the upper track biases the locking pin 434 radially outward in theouter portion 412 a of the locking pin slot, i.e., away from the ledge412 c. Further squeezing of the handle body 374 and main housing 372causes the locking pin 434 ultimately to reach the inner track 442, uponwhich the force of the locking pin spring 436 causes the locking pin 434to slide into the inner track 442 until the locking pin 434 againencounters the ledge 412 c of the locking pin slot. At this point, ifthe handle body 374 is released, the locking pin 434 will settle intothe inner track trough 443, corresponding with the “neutral position.”The end effector 214 will remain in the neutral position upon release ofthe handle 374. An additional activation of the handle 374 will drivethe locking pin 434 distally through the lower portion of the innertrack 442 until the locking pin 434 slides into the lower track 446, atwhich point the handle body 374 may be released and the actuatormechanism 370 returned to the “fully open position.” The foregoing cyclecorresponds with a transition from the “fully open position” to the“neutral position” and returning again to the “fully open position.”

In an alternative cycle, the locking pin 434 starts at the fully openposition 447 and is advanced by the linkage arm 378 so that the lockingpin 434 traverses the upper track 440. The ramped surface of the uppertrack biases the locking pin 434 radially outward in the outer portion412 a of the locking pin slot, i.e., away from the ledge 412 c. Furthersqueezing of the handle body 374 and main housing 372 causes the lockingpin 434 ultimately to reach the outer track 444 of the locking pin track438, preventing any further rotation of the handle body 374 relative tothe main housing 372. As the user releases the squeezing action on thehandle body 374, the linkage arm 378 will rotate slightly in theclockwise direction (as shown in FIG. 23), releasing the locking pin 434from the ledge 412 c of the locking pin slot and into the trough 445formed in the outer track 444, corresponding with the “fully closedposition,” where it is retained under the force of the locking pinspring 436. Upon re-squeezing by the user of the handle body 374relative to the main housing 372, the edge of the inner portion 412 b ofthe locking pin slot engages the locking pin 434, forcing the lockingpin 434 out of the trough 445 of the outer track. The spring force ofthe locking pin spring 436 pulls the locking pin 434 downward from theouter track 444 into the intersection of the outer track 444 with thelower track 446. As the handle body 374 is released by the user, thelinkage arm 378 rotates clockwise (as shown in FIG. 23) and the lockingpin 434 is allowed to traverse the lower track 446 proximally until thelocking pin 434 returns to the starting position. The foregoing cyclecorresponds with a transition from the “fully open position” to the“fully closed position” and returning again to the “fully openposition.”

Those skilled in the art will recognize that the handle lock mechanism430 embodiment described herein may be modified to provide a range ofmovement different from that provided by the embodiment shown in orderto support other and different functions or processes to be performed bythe device associated with the actuator mechanism 370. For example, asingle cycle may include more or fewer grooves and intersections.Variations of other parameters and components are also possible.

As shown in FIGS. 21 and 22A, the exterior surface of the main housing372 includes a plurality of handle position indicator windows, includinga “fully open window” 373 a, a “neutral position window” 373 b, and a“fully closed window” 373 c. Each of the windows comprises an openinginto the interior of the main housing 372 that is located within thetravel path of the drive arm 378 b of the linkage arm. Accordingly, asthe actuator mechanism 370 is transitioned between the fully open,neutral, and fully closed positions, the drive arm 378 b is locatedwithin the corresponding window, thereby providing a visual indicator onthe main housing 372 of the position of the actuator mechanism 370. Theposition indicator may be highlighted by providing a lighted, brightlycolored, or otherwise visually observable member on the drive arm 378 bin a position observable through the windows 373 a, 373 b, 373 c.

Turning to FIGS. 23 through 27A-D, the structure and function of aneedle stop assembly and a handle stop assembly of the actuatormechanism 370 will be described. The needle stop assembly operates toprevent translation of the needle launch button 394 when the actuatormechanism 370 is not in the “fully closed position.” This preventsunintended advancement of the needle deployment assembly 450 prior totissue engagement. The handle stop assembly operates to prevent thehandle body 374 from being transitioned out of the fully closed positionwhen the needle deployment assembly 450 is in anything other than thefully retracted position.

First, the needle stop assembly includes a needle stop arm 490 that ispivotably attached to or mounted within the main housing 372. The needlestop arm 490 is a substantially “L”-shaped member having a longitudinalleg 492 and a transverse leg 494. A pivot pin 496 or other suitablemember extends transversely from at least one side of the longitudinalleg 492 to provide a pivot axis about which the needle stop arm 490 isable to pivot upon attachment or mounting within the main housing 372.The pivot pin 496 also bisects the longitudinal leg 492 into a proximalsection 492 a and a distal section 492 b. A spring pin 498 or othersuitable member also extends transversely from at least one side of thelongitudinal leg 492 to provide an abutment surface for a stop membertorsion spring 500 that is mounted on the pivot pin 496, as shown inFIGS. 27A and 27C. In the embodiment shown, the spring pin 498 islocated on the proximal section 492 a of the longitudinal leg 492. Thetorsion spring 500 also abuts an inner surface of the main housing 372to thereby provide a stop member torsion spring force that tends torotate the needle stop arm 490 in the clockwise direction (from theperspective of FIGS. 27A and 27C) around the axis of the pivot pin 496.

During operation, the needle stop arm 490 is in the engaged positionillustrated in FIGS. 23 and 27A when the handle body 374 is in the openposition relative to the main housing 372. In the engaged position, theproximal tip of the proximal section 492 a engages a distal pocket 502or the distal-facing portion of the base portion 394 a of the needlelaunch button, thereby preventing distal movement of the needle launchbutton 394 relative to the main housing 372. The needle stop arm 490remains in the engaged position, under the biasing force of the needlestop torsion spring 500, until it is acted upon by the linkage arm 378.This occurs when the handle body 374 is moved to the closed positionrelative to the main housing 372 as shown, for example, in FIG. 24. Atthat point, the handle body arm 378 c engages the downward facingtransverse leg 494 of the needle stop arm, driving the transverse leg494 upward (from the perspective of FIG. 24) and rotating the needlestop arm 490 in the clockwise direction (from the perspective of FIG.24). This rotation causes the proximal tip of the proximal section 492 ato disengage from the distal pocket 502 (or other engagement surface) ofthe base portion 394 a of the needle launch button, thereby allowing theneedle launch button 394 to be translated in the distal direction. Theneedle launch button 394 remains free to translate within the housing372 until the needle launch button 394 is moved to the proximal startingposition (shown, for example, in FIGS. 23 and 27A-B) and the handle body374 is moved from the closed position.

Turning next to the handle stop assembly, the assembly includes a handlestop arm 510 that is rotatably attached to or mounted within the mainhousing 372 near its proximal end. The handle stop arm 510 is locatedbeneath the needle launch button 394 when the needle launch button 394is in its proximal-most location, corresponding with the needledeployment assembly 450 being fully retained within the actuatormechanism 370. The handle stop arm 510 is rotatably supported by androtates around an axis defined by a pivot pin 512. A handle stop torsionspring 514 is mounted over the pivot pin 512 and has a first leg that isfixed within or abutting against a portion of the interior of the mainhousing 372 and a second leg that abuts a portion of the handle stop arm510 to provide a spring biasing force tending to cause the handle stoparm 510 to rotate counterclockwise (from the perspective of FIGS. 23 and24) around the axis defined by the pivot pin 512.

During operation, the handle stop arm 510 is in the retracted positionillustrated in FIGS. 23 and 24 when the needle launch button 394 is inthe proximally-retracted position relative to the main housing 372. Inthe retracted position, the handle stop arm 510 is disposed fully withina recess 516 formed in the underside of the main housing 372 and isretained there against the spring force of the torsion spring 514 by theunderside of the base portion 394 a of the needle launch button 394.Once the needle launch button 394 is advanced distally, the handle stoparm 510 is free to rotate counterclockwise (from the perspective ofFIGS. 23 and 24) under the biasing force of the torsion spring 514 untilthe handle stop arm 510 projects downward from the underside of the mainhousing 372, as shown in FIG. 24. Rotation of the handle stop member 510is limited by an engagement of the distal surface 511 of the handle stoparm against a proximal stop surface 518 defined by the main housing 372.When the needle launch button 394 is returned to the proximal position,the underside of the base portion 394 a once again engages the handlestop arm 510 and causes the handle stop arm 510 to rotate clockwise(from the perspective of FIGS. 23 and 24) to return to the retractedposition. In this way, the handle stop arm 510 is able to prevent thehandle body 374 from being activated from the fully closed position(shown in FIG. 24) unless the needle actuator button 394 is in the fullyretracted position, corresponding with full retraction of the needledeployment assembly 450 within the actuator mechanism 370.

Turning next to FIGS. 30-36, another embodiment of a needle deploymentassembly 450 is shown. The needle deployment assembly 450 is configuredfor use with the actuator mechanism 370 described above in relation toFIGS. 21 through 29. The assembly 450 includes a rigid body portion 452and a flexible catheter portion 454 extending distally from the distalend of the rigid body portion 452. A needle 456 is fixed to the distalend of the catheter portion 454. The upper surface of the rigid bodyportion 452 includes an elongated groove 458 that provides access intothe generally tubular rigid body 452. A suture deployment button 460extends from the interior of the rigid body portion 452 through thegroove 458.

In the embodiments shown, the suture deployment button 460 is attachedto or formed integrally with a cable bushing 462 that is concentricallyand slidably retained within an internal lumen defined by the rigid bodyportion 452 of the assembly. The cable bushing 462 is attached by a snapconnect 463 to a cinch bushing 466, which is attached to a section ofhypo tube 467 having an elongated pusher coil 466 attached at itsopposite end. The combined assembly of the cable bushing 462, hypo tube467, and pusher coil 466 is aligned and has a shape and size adapted toslide coaxially within the rigid body portion 452 and flexible catheterportion 454, as explained more fully below. The cable bushing 462includes an internal counterbore 470 and a cable lumen 472 extendingthrough the proximal end of the bushing 462. A looped cable 464 (e.g.,nitinol, stainless steel, cable, or braid) extends concentricallythrough the pusher coil 466, hypo tube 467, and through the cable lumen472 and into the void formed by the counterbore 470 of the cable bushing462. A crimp tube 465 or other suitable retaining member is formed onthe proximal end of the looped cable 464 and has a size and shape thatprevents the crimp tube 465 from passing distally through the cablelumen 472. In the embodiment shown, the pusher coil 466 is a coiled wiredefining a central lumen through which the looped cable 464 extendssubstantially concentrically.

Turning next to FIGS. 36A-C, the structure of the anchor assembly 48 isshown. The anchor assembly 48 includes a distal anchor 50 a, a proximalanchor 50 b, a suture 52, and a cinch 62. A knot 54 is formed at thedistal end of the suture 52. A proximal end of the suture 52 isreleasably attached to a distal end of the looped cable 464 in a mannerdescribed below.

The operation of the needle deployment assembly 450 will now bedescribed. A starting point is shown in FIGS. 30A, 32A, and 36A, inwhich the suture deployment button 460 is at its proximal-most extent.As the suture deployment button 460 is advanced distally, the cablebushing 462, cinch bushing 466, hypo tube 467, and pusher coil 468 areadvanced distally, thereby driving the anchor assembly 48 distally untilthe anchor assembly 48 exits the catheter body 452 through the needle456. (See FIG. 36B). In an embodiment, the distal anchor 50 a andproximal anchor 50 b are advanced in separate steps, as described morefully below. After full advancement, the distal face of the cinchbushing 466 engages a one way snap feature 474 located near the distalend of the rigid body portion 452 of the needle deployment assembly 450.(See FIG. 30D). In the embodiment shown, the one way snap feature 474includes an inward facing tab 476 that is oriented to be resilientlybiased outward as the distal face of the cinch bushing 466 engages thetab 476, and then to snap inward after the cinch bushing 466 passesdistally. This action traps the cinch bushing 466 at a location distalof the inward facing tab 476, which prevents proximal movement of thecinch bushing 466 past the tab 476. A distal inward facing tab 478prevents over-translation of the cinch bushing 466.

Once the one way snap feature 474 has engaged the cinch bushing 466,retraction of the suture deployment button 460 causes the cable bushing462 to separate from the cinch bushing 466 at the location of the snapconnect 463. (See FIGS. 34A-B). The snap connect 463 mates the cinchbushing 466 to the cable bushing 462 until a predetermined load isplaced upon the snap connect 463, at which point the snap connect 463fails and the cinch bushing 466 will separate from the cable bushing462. As the suture deployment button 460 is then retracted proximally,the crimp tube 465 will seat within the counterbore 470 of the cablebushing 462 and the cable 464 is retracted as the pusher coil 468remains fully extended. The distal end of the pusher coil 468 has adiameter that substantially matches up with the diameter of the cinch62, whereby the pusher coil 468 prevents proximal movement of the cinch62 and any of the components retained on the suture 52 on the distalside of the cinch 62. As the knot 64 engages the distal portion of thedistal anchor 50 a, further retraction of the button 460 causes theanchors 50 a, 50 b to transition to their expanded deployment state.(See FIG. 36C).

In the embodiment shown, the anchor assembly 48 includes a separationfeature that facilitates separation of the anchor assembly 48 from thelooped cable 464, thereby providing the ability to deposit the anchorassembly 48 and separate it from the delivery device without the need tocut the suture 52. As shown in FIG. 35C, a proximal end 53 of the suture52 is folded over to releasably engage the distal end of the loopedcable 464. In operation, after the anchor assembly 48 has been deployed,the needle deployment assembly 450 is disengaged from the actuatormechanism 370 and is retracted out of the proximal end of the mainhousing 372. During this withdrawal, the anchor assembly 48, which isfixed to the tissue, prevents the suture 52 from being withdrawn, whichdrags the looped cable 464 out of the distal end of the pusher coil 468.The crimp tube 465 seats in the counter bore 470 of the cable bushing 42and drags the suture deployment button 460 distally for a distancesufficient to release the suture 52. Once the looped cable 464 isdragged out of the distal end of the pusher coil 468, the proximal end53 of the suture 52 that is folded over the distal end of the loopedcable 464 will release from the cable 464, thereby freeing the anchorassembly 48 from the needle deployment assembly 450.

Those skilled in the art will appreciate that other anchor assemblyrelease features or suture cutting devices and methods may be suitablefor separating the anchor assembly 48 from the delivery device.

Turning next to FIGS. 28A-C and 29A-C, additional details of thestructure and operation of the needle deployment assembly actuationmechanism 390 are shown. As described above, the mechanism includes aneedle launch track 396 that is fixed to the main housing 372 above thedrive channel 422, and a needle launch button 394. The launch track 396defines a channel 397 in which the button 394 is able to slidelongitudinally under control of the user. The button 394 includes a baseportion 394 a and a top portion 394 b that are attached to each other,with the base portion 394 a sliding within the launch track channel 397and the top portion 394 b extending above the launch track 396 to beaccessible to the user. In the embodiment shown, the base portion 394 aand top portion 394 b of the button 394 are attached by a tab and slotmechanism, although other attachment mechanisms are also suitable. Aneedle lock leaf spring 399 is positioned within the button 394. Theleaf spring 399 includes a locking tab 399 a that extends through a leafspring slot 395 formed in the base portion 394 a of the button.

The locking tab 399 a is biased outward through the leaf spring slot 395to engage one of the cutouts 398 formed on the needle launch track 396.When the locking tab 399 a is engaged in one of the cutouts 398, theleaf spring 399 prevents the needle launch button 394 from moving alongthe needle launch track 396. By applying a lateral(longitudinally-directed) force on the top portion 394 b of the button,the user is able to bias the leaf spring locking tab 399 a inward, awayfrom the launch track 396, thereby disengaging the tab 399 a from acutout 398 and allowing the user to slide the needle launch button 394within the launch track channel 397.

As shown in FIGS. 25A-B, the proximal end of the needle deploymentassembly includes a cap 480 having a resilient arm 481 terminating in anoutwardly directed hook 482. The hook 482 has a size and shape adaptedto engage and be releasably retained within a pocket 484 defined by thebase portion 394 a of the needle launch button 394. In alternativeembodiments, the cap 480 includes a plurality of resilient arms eachhaving a hook, and the base portion 394 a includes a plurality ofpockets configured to engage the plurality of hooks. The needledeployment assembly 450 is loaded into the actuator mechanism 370 byinserting the distal end of the needle deployment assembly 450 (i.e.,the needle body 456) into the proximal end of the main housing 372 anddirecting the needle body 456 and flexible catheter body 454 distallythrough the lumen defined by the launch tube 228 extending through thetubular body 212. After the rigid body portion 452 is loaded into theactuation channel 424, the hook 482 engages the needle launch button 394and the resilient arm 481 is biased inwardly until the hook 482encounters the pocket 484 of the needle launch button 394, at whichpoint the hook 482 will snap into the pocket 484 to thereby releasablymate the needle deployment assembly 450 to the actuator, mechanism 370.In this manner, movement of the needle launch button 394 within thedrive channel 422 causes movement of the needle deployment assembly 450relative to and concentrically within the launch tube 228. The needledeployment assembly 450 may be disengaged from the actuator mechanism370 by the user by forcing the resilient arm 481 inward to disengage thehook 482 from the pocket 484.

FIGS. 24 and 25A show the rigid proximal portion 82 of the tubular body212 extending from the distal end of the main housing 372. A distalshoulder 383 is defined on the interior of the tubular body 212 at thepoint of transition between the rigid proximal portion 82 and theflexible portion of the tubular body 212. The distal end of a launchtube spring 384 rests against the shoulder 383 in the annular spacebetween the rigid proximal portion 82 of the tubular body and the launchtube 228. A needle deployment assembly loading sleeve cap 385 comprisesa transition point between a larger diameter portion of the launch tube228 a near the proximal end of the device and a smaller diameter portionof the launch tube 228 b extending distally through the flexible tubularbody 212. The loading sleeve cap 385 defines a proximal shoulder 386against which the proximal end of the launch tube spring 384 abuts. Inthis manner, when the launch tube 228 is advanced distally, the launchtube spring 384 is compressed between the distal shoulder 383 and theproximal shoulder 386. The spring force of the launch tube spring 384thereby provides a force biasing the launch tube 228 proximally. Thisproximally-directed spring force provides resistance against a forcesqueezing the handle body 374 against the main body 372, thereby biasingthe handle body 374 to the open position.

The spring force provided by the launch tube spring 384 also facilitatesthe operation of the handle lock mechanism 430 described above inrelation to FIGS. 26A-B. In particular, the proximally-directed springforce applied to the launch tube 228 is transferred to the locking pin434 through the drive bushing 420, drive bushing pin 408, and linkagearm 378. This force facilitates the movement of the locking pin 434proximally through the lower track 446 during the return portion of thecycle. As the locking pin 434 moves proximally within the lower track446, the ramped lower surface of the lower track 446 causes the lockingpin 434 also to move upward in the inner portion 412 a of the lockingpin slot in order to return to the starting position 447 in which thelocking pin 434 rests on the ledge 412 c.

The interior of the loading sleeve cap 385 defines a surface againstwhich the distal-most portion of the rigid body portion 452 of theneedle deployment assembly 452 abuts during loading of the assembly,while allowing passage of the flexible catheter portion 454 through thelumen defined by the launch tube 228.

The combined operation of the actuator mechanism 370 and needledeployment assembly 450 will now be described. As shown in FIG. 7, theend effector 214 is located at a point near a target region of tissue,at which point the jaws 220, 222 are opened under control of theactuator mechanism 370. After the tissue is placed between the jaws 220,222, the handle body 374 is squeezed toward the main housing 372, whichcauses the launch tube 228 to advance distally, closing the jaws 220,222 upon the tissue. The distal portion of the launch tube 228 is alsotransitioned to an arcuate shape in which the distal opening of thelaunch tube 228 is positioned substantially perpendicularly to thetissue grasped between the jaws 220, 222. At this point, the locking pin434 is positioned in the trough 445 of the outer track 444, therebymaintaining the actuator mechanism 370 in a “closed” positioncorresponding with a closed position of the jaws 220, 222.

Once the tissue has been grasped and the launch tube 228 positioned asdescribed above, the needle launch button 394 is advanced distallywithin the launch track 396, thereby causing the needle deploymentassembly 450 to be advanced through the launch tube 228. The needlelaunch button 394 is then locked in place by allowing the leaf spring399 to engage one of the cutouts 398 of the needle launch track 396. Theneedle 456 pierces and extends through the tissue, as shown in FIG. 7.In an embodiment, the length of travel allowed for the needle launchbutton 394 within the launch track 396 is such that the needle 456 isprevented from extending past a desired distance beyond the lower jaw220. Once the needle 456 is in its proper position, the distal anchor 50a is deployed by advancing the suture deployment button 460 a distancesufficient to extend the distal anchor 50 a out of the needle 456 of theneedle deployment assembly 450, as shown in FIG. 7. The distal anchor 50a is thereby deployed on the distal side of the tissue fold held by thejaws 220, 222. After the distal anchor 50 a is deployed, the needlelaunch button 394 is retracted, thereby retracting the needle 456 fromthe tissue and into the launch tube 228. The jaws 220, 222 aredisengaged from the tissue by squeezing and releasing the handle body374 and main housing 372. As a result, the suture 52 extends through thetissue as the proximal anchor 50 b remains within the needle deploymentassembly 450. The proximal anchor 50 b may then be deployed.

The suture deployment button 460 is then advanced distally, causing theproximal anchor 50 b to be extended outside of the needle body 456 andthe needle deployment assembly 450. (See, e.g., FIGS. 36B-C). Theproximal anchor 50 b is located on the proximal side of the tissue fold.At this point, the cinch bushing 466 engages the one way snap feature474 to lock the cinch bushing 466 in place, thereby locking in place thehypo tube 467 and pusher coil 468. The suture deployment button 460 isthen withdrawn proximally, releasing the snap connect 463 attaching thecinch bushing 466 to the cable bushing 462 and causing the looped cable464 to be withdrawn relative to and through the pusher coil 468. Thisaction causes the suture 52 to be retracted proximally through thedistal anchor 50 a, proximal anchor 50 b, and the cinch 62, therebyfully deploying the anchor assembly 48. (See, e.g., FIG. 36C). Theanchor assembly 48 is thereby deployed to retain a tissue fold F, asshown schematically in FIG. 1B.

The resilient arm 481 of the needle deployment assembly cap 480 is thenbiased inward to release the hook 482 from the needle launch buttonpocket 484, thereby releasing the needle deployment assembly 450 fromthe actuator mechanism 370. As the needle deployment assembly 450 iswithdrawn, the looped cable 464 is dragged out of the distal end of thepusher coil 468, thereby releasing the folded proximal portion of thesuture 53 from the looped cable 464.

The devices described herein are suitable for use in many diagnostic andtherapeutic procedures in which tissue manipulation and securement isperformed endoscopically or endolumenally. Examples of such proceduresinclude endolumenal treatment of obesity (see, e.g., U.S. ProvisionalPatent Application Ser. No. 61/038,487, filed Mar. 21, 2008, herebyincorporated by reference), revision of obesity procedures (see, e.g.,U.S. patent application Ser. No. 11/342,288, filed Jan. 27, 2006, herebyincorporated by reference), treatment of gastroesophageal reflux disease(GERD) (see, e.g., U.S. patent application Ser. No. 11/290,304, filedNov. 29, 2005, hereby incorporated by reference), gastrotomy closureprocedures (see, e.g., U.S. patent application Ser. No. 11/238,279,filed Sep. 28, 2005, hereby incorporated by reference), wound closure,fistula repair, and other procedures in which two or more portions oftissue are grasped, manipulated, approximated, or secured. Additionalexamples of procedures are described in the other patent applicationsincorporated by reference herein.

Although various illustrative embodiments are described above, it willbe evident to one skilled in the art that various changes andmodifications are within the scope of the invention. It is intended inthe appended claims to cover all such changes and modifications thatfall within the true spirit and scope of the invention.

The invention claimed is:
 1. A surgical instrument comprising: a tubularbody; a launch tube extending through the tubular body; a needleassembly movable within the launch tube; an end effector attached to adistal end of the tubular body by a pivotable coupling, with the endeffector having a first bail and a second bail; with a distal end of thelaunch tube attached to the first bail via a fitting allowing the distalend of the launch tube to pivot relative to the first bail and also toslide linearly from a first position where the distal end of the launchtube is substantially on a first side of the first bail, to a secondposition where the distal end of the launch tube is substantially on asecond side of the first bail, opposite from the first side.
 2. Thesurgical instrument of claim 1 with the first bail fixed in positionrelative to the second bail and substantially parallel to the secondbail.
 3. The surgical instrument of claim 1 further comprising an endslot in a distal end of the first bail, and a suture cutter blade on thefirst bail, between the slot and the fitting.
 4. The surgical instrumentof claim 3 further comprising an end slot in a distal end of the secondbail.
 5. The surgical instrument of claim 3 with the end slotsubstantially laterally centered on the first bail.
 6. A surgicalinstrument comprising: a tubular body; a launch tube extending throughthe tubular body; a needle assembly movable within the launch tube; anend effector attached to a distal end of the tubular body by a pivotablecoupling, with the end effector having a first bail and a second bail;with a distal end of the launch tube attached to the first bail via afitting allowing the distal end of the launch tube to pivot relative tothe first bail, the fitting including left and right side pivot slots,and with left and right side pivot pins on the first bail engaged intothe left and right side pivot slots, respectively, and with the launchtube linearly slidable between upper and lower ends of the pivot slots.7. The surgical instrument of claim 1 further comprising a graspersupported on a slider slidable along a slide slot in the second bail. 8.The surgical instrument of claim 1 wherein the launch tube issubstantially parallel to the first bail when the launch tube is in thefirst position.
 9. The surgical instrument of claim 8 wherein the launchtube is at an acute angle to the first bail when the launch tube is inthe second position.
 10. The surgical instrument of claim 1 with acenterline between the first and second bails off set from a center lineof the tubular body.
 11. The surgical instrument of claim 1 wherein thefitting comprises a pivot/slide fitting permanently positioning a frontend of the launch tube between a front end of the first jaw and a frontend of the tubular body.
 12. The surgical instrument of claim 1 with thelaunch tube having a linearly slidable range of movement limited by thefitting.
 13. A surgical instrument comprising: a tubular body; a launchtube extending through the tubular body; a needle assembly in the launchtube; an end effector attached to a distal end of the tubular body by apivotable coupling, with the end effector having a first bail and asecond bail; with a distal end of the launch tube attached to the firstbail via a fitting allowing the distal end of the launch tube to pivotrelative to the first bail and also allowing the distal end of thelaunch tube to slide from a first position where the distal end of thelaunch tube is substantially on a first side of the first bail, to asecond position where the distal end of the launch tube is substantiallyon a second side of the first bail, opposite from the first side; and asuture cutter blade adjacent to a distal end of the first bail.
 14. Asurgical instrument comprising: a tubular body; an end effector attachedto the front end of the tubular body, with the end effector having afirst jaw and a second jaw pivotally attached to the first jaw; and alaunch tube extending out of a front end of the tubular body, with afront end of the launch tube attached to the first jaw via a pivot/slidefitting allowing the front end of the launch tube to pivot relative tothe first jaw and to also shift linearly relative to the first jaw; anda needle assembly in the launch tube, with a needle of the needleassembly linearly slidable out from a distal end of the launch tube. 15.The surgical instrument of claim 14 with the second jaw longer than thefirst jaw, and with a back end of the second jaw pivotally attached tothe tubular body, and with a back end of the first jaw pivotallyattached onto the second jaw at a position between the back end and afront end of the second jaw.
 16. The surgical instrument of claim 14with the first jaw having a central longitudinal opening and with thelaunch tube positioned in the central longitudinal opening.
 17. Thesurgical instrument of claim 14 with the launch tube slidable in adirection substantially perpendicular to a central longitudinal axis ofthe launch tube.
 18. The surgical instrument of claim 14 with the launchtube having a linearly slidable range of movement limited by thepivot/slide fitting.